FDA Product Code
FDA Product Code GDW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4750
510(k) Clearances — 284 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254291 | easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges | Ezisurg Medical Co., Ltd. | 2026-09-25 | Traditional | PDF ↗ |
| K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm) | Ethicon Endo-Surgery, LLC | 2026-05-11 | Traditional | PDF ↗ |
| K253657 | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads | Covidien (Part of Medtronic) | 2026-04-10 | Traditional | PDF ↗ |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T) | Ethicon Endo-Surgery, LLC | 2025-12-17 | Traditional | PDF ↗ |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) | Ethicon Endo-Surgery, LLC | 2025-05-14 | Traditional | PDF ↗ |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Stapler (GTX90); ECHELON LINEAR Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR Stapler 3D 90mm Green Reload (GTXR90G) | Ethicon Endo-Surgery, LLC | 2025-02-25 | Traditional | PDF ↗ |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) | Ethicon Endo-Surgery, LLC | 2024-10-28 | Traditional | PDF ↗ |
| K242679 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series) | Fengh Medical Co., Ltd. | 2024-10-04 | Special | PDF ↗ |
| K222487 | Anika Tissue Tack Fixation System | Anika Therapeutics, Inc. | 2023-05-08 | Traditional | PDF ↗ |
| K222210 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2023-04-21 | Traditional | PDF ↗ |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR Cutters 100mm Green Reload (GLCR100G) | Ethicon Endo-Surgery | 2023-03-15 | Traditional | PDF ↗ |
| K211197 | Disposable Endoscopic Cutter Stapler and Cartridge | Changzhou Waston Medical Appliance Co., Ltd. | 2023-01-19 | Traditional | PDF ↗ |
| K221771 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2022-11-30 | Traditional | PDF ↗ |
| K222641 | Signia Small Diameter Reloads Including Regular (Round) Tip Version | Covidien | 2022-11-29 | Traditional | PDF ↗ |
| K221003 | Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA | Covidien | 2022-09-30 | Traditional | PDF ↗ |
| K221013 | GIA Auto Suture Stapler with DST Series Technology | Covidien | 2022-05-05 | Special | PDF ↗ |
| K221005 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2022-04-29 | Special | PDF ↗ |
| K221006 | GIA Stapler with Tri-Staple Technology | Covidien | 2022-04-29 | Special | PDF ↗ |
| K211811 | Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers | Wuxi Beien Surgery Device Co., Ltd. | 2022-03-03 | Traditional | PDF ↗ |
| K211458 | Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers | Ningbo Verykind Medical Device Co., Ltd. | 2021-12-30 | Traditional | PDF ↗ |
| K201934 | Surgimatix Absorbable Fixation System | Surgimatix, Inc. | 2021-10-01 | Traditional | PDF ↗ |
| K210909 | easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use | Ezisurg Medical Co., Ltd. | 2021-06-24 | Traditional | PDF ↗ |
| K201639 | Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2021-05-27 | Traditional | PDF ↗ |
| K202709 | Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges | Ningbo Verykind Medical Device Co., Ltd. | 2021-05-18 | Traditional | PDF ↗ |
| K210278 | Titan SGS | Standard Bariatrics | 2021-04-28 | Traditional | PDF ↗ |
| K200320 | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload | M/s. Meril Endo Surgery Private Limited. | 2021-02-05 | Traditional | PDF ↗ |
| K202507 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2021-01-21 | Traditional | PDF ↗ |
| K203117 | TissueTak device | Via Surgical , Ltd. | 2021-01-07 | Traditional | PDF ↗ |
| K202467 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads | Fengh Medical Co., Ltd. | 2020-12-14 | Special | PDF ↗ |
| K202701 | GIA Stapler with Tri-Staple Technology | Covidien | 2020-12-07 | Special | PDF ↗ |
| K202864 | Tri-Staple 2.0 Reloads | Covidien | 2020-10-28 | Special | PDF ↗ |
| K202665 | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm | Ethicon Endo-Surgery, LLC | 2020-10-15 | Special | PDF ↗ |
| K201882 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2020-10-09 | Traditional | PDF ↗ |
| K201280 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed | Ethicon Endo-Surgery, LLC | 2020-07-27 | Special | PDF ↗ |
| K201672 | Signia Stapler (with new software) | Covidien | 2020-07-17 | Special | PDF ↗ |
| K200420 | Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green | Ethicon Endo-Surgery, LLC | 2020-06-29 | Traditional | PDF ↗ |
| K192720 | GIA Stapler with Tri-Staple Technology | Covidien | 2020-03-13 | Traditional | PDF ↗ |
| K192330 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2020-01-23 | Traditional | PDF ↗ |
| K190884 | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool | Datascope Corp. | 2019-12-26 | Traditional | PDF ↗ |
| K182476 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads | Fengh Medical Co., Ltd. | 2019-12-18 | Traditional | PDF ↗ |
| K190331 | Applied Medical Laparoscopic Linear Cutter | Applied Medical Resources Corporation | 2019-11-22 | Traditional | PDF ↗ |
| K192566 | Reach and CQ'ENCE Circular Staplers | Reach Surgical, Inc. | 2019-10-17 | Special | PDF ↗ |
| K191070 | Signia Small Diameter Reloads | Covidien | 2019-09-04 | Traditional | PDF ↗ |
| K191287 | OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners | Davol Inc., Subsidiary of C.R. Bard | 2019-07-16 | Special | PDF ↗ |
| K182217 | Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use | Ezisurg (Suzhou) Medical Co., Ltd. | 2019-04-16 | Traditional | PDF ↗ |
| K182475 | Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) | Covidien | 2019-03-14 | Traditional | PDF ↗ |
| K181668 | FasTouch Absorbable Fixation System | Via Surgical , Ltd. | 2019-03-13 | Traditional | PDF ↗ |
| K183477 | easyPPHTM Hemorrhoidal Stapler for Single Use | Ezisurg Medical Co., Ltd. | 2019-02-11 | Traditional | PDF ↗ |
| K183435 | Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black | Ethicon Endo-Surgery, LLC | 2019-02-06 | Traditional | PDF ↗ |
| K181657 | easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use | Ezisurg Medical Co., Ltd. | 2019-02-01 | Traditional | PDF ↗ |
| K180175 | SignalMark Lung Biopsy Site Marker | View Point Medical, Inc. | 2018-12-07 | Traditional | PDF ↗ |
| K182380 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2018-11-28 | Traditional | PDF ↗ |
| K181620 | Endoscopic Linear Cutting Staplers and Loading Units for Single Use | Ezisurg (Suzhou) Medical Co., Ltd. | 2018-09-18 | Traditional | PDF ↗ |
| K181653 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed | Ethicon Endo-Surgery, LLC | 2018-09-18 | Traditional | PDF ↗ |
| K173270 | Tri-Staple 2.0 Reinforced Reload | Covidien | 2018-02-20 | Traditional | PDF ↗ |
| K172361 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2018-02-16 | Traditional | PDF ↗ |
| K173443 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2018-02-01 | Traditional | PDF ↗ |
| K172960 | easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use | Ezisurg Medical Co., Ltd. | 2017-12-21 | Traditional | PDF ↗ |
| K172561 | Disposable Circular Stapler | Changzhou Kangdi Medical Stapler Co., Ltd. | 2017-12-05 | Special | PDF ↗ |
| K172538 | Disposable Linear Stapler, Disposable Linear Cutter | Changzhou Kangdi Medical Stapler Co., Ltd. | 2017-11-30 | Special | PDF ↗ |
| K171589 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2017-11-17 | Traditional | PDF ↗ |
| K171561 | Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload | Dextera Surgical, Inc. | 2017-08-28 | Traditional | PDF ↗ |
| K162707 | Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload | Golden Stapler Surgical Co., Ltd. | 2017-07-14 | Traditional | PDF ↗ |
| K170278 | OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners | C.R. Bard, Inc. | 2017-05-31 | Traditional | PDF ↗ |
| K163523 | ECHELON CIRCULAR Powered Stapler | Ethicon Endo-Surgery, LLC | 2017-04-18 | Traditional | PDF ↗ |
| K163698 | OptiFix Open Absorbable Fixation System - 20 absorbable fasteners | C.R. Bard, Inc. | 2017-04-11 | Traditional | PDF ↗ |
| K162947 | Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler | Chongqing Qmi Surgical Co., Ltd. | 2017-03-03 | Traditional | PDF ↗ |
| K170348 | Signia Four-Bay Smart Charger (to be used with Signia Stapler) | Covidien | 2017-03-02 | Special | PDF ↗ |
| K162710 | Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload | Tgs Medical Co., Ltd. | 2017-02-09 | Traditional | PDF ↗ |
| K163454 | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm | Ethicon Endo-Surgery, LLC | 2017-01-05 | Special | PDF ↗ |
| K160969 | ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler | Shinemed, LLC | 2016-12-12 | Traditional | PDF ↗ |
| K163098 | Tri-Staple 2.0 Intelligent Cartridge | Covidien, LLC | 2016-12-05 | Special | PDF ↗ |
| K161757 | Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads | Victor Medical Instruments Co., Ltd. | 2016-12-05 | Traditional | PDF ↗ |
| K161905 | Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2016-11-17 | Traditional | PDF ↗ |
| K162252 | FasTouch Fixation System | Via Surgical , Ltd. | 2016-11-14 | Special | PDF ↗ |
| K161137 | Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload | Cardica, Inc. | 2016-07-20 | Traditional | PDF ↗ |
| K160900 | CapSure Fixation System - Straight 5mm x 37 cm 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm 15 Permanent fasteners | C.R. Bard, Inc. | 2016-05-31 | Traditional | PDF ↗ |
| K160176 | Signia Stapler | Covidien | 2016-04-26 | Traditional | PDF ↗ |
| K153202 | iMESH Tacker | Thd Lap | 2016-03-24 | Special | PDF ↗ |
| K160521 | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm | Ethicon Endo-Surgery, LLC | 2016-03-22 | Special | PDF ↗ |
| K151081 | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge | Cardica, Inc. | 2016-01-15 | Traditional | PDF ↗ |
| K152618 | PANTHER Cutter Stapler | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2015-11-12 | Traditional | PDF ↗ |
| K151659 | ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks | Covidien, LLC | 2015-07-17 | Special | PDF ↗ |
| K142577 | PANTHER Endo Linear Cutter Staplers with Single Use Loading Units | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2015-06-11 | Traditional | PDF ↗ |
| K151163 | Signia Loading Unit, Tri-Staple 2.0 Cartridge | Covidien, LLC | 2015-05-29 | Special | PDF ↗ |
| K150026 | Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler | Ethicon Endo-Surgery, LLC | 2015-05-18 | Traditional | PDF ↗ |
| K142873 | OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners | C.R. Bard, Inc. | 2015-03-12 | Traditional | PDF ↗ |
| K142808 | CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners | C.R. Bard, Inc. | 2015-03-09 | Traditional | PDF ↗ |
| K143129 | easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit) | Ezisurg Medical Co., Ltd. | 2015-01-29 | Traditional | PDF ↗ |
| K141952 | ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED | Ethicon Endo-Surgery, Inc. | 2014-11-24 | Traditional | PDF ↗ |
| K141097 | CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE | Touchstone International Medical Science Co., Ltd. | 2014-09-26 | Traditional | PDF ↗ |
| K141367 | LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS | Touchstone International Medical Science Co., Ltd. | 2014-07-25 | Traditional | PDF ↗ |
| K140560 | ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING | Ethicon Endo-Surgery, LLC | 2014-04-22 | Traditional | PDF ↗ |
| K140609 | RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS | Covidien | 2014-04-09 | Special | PDF ↗ |
| K131563 | SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM | Opus Ksd, Inc. | 2014-04-09 | Traditional | PDF ↗ |
| K132698 | FASTOUCH FIXATION SYSTEM | Via Surgical , Ltd. | 2014-03-14 | Traditional | PDF ↗ |
| K140118 | MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE | Cardica, Inc. | 2014-02-25 | Special | PDF ↗ |
| K140170 | MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE | Cardica, Inc. | 2014-02-19 | Special | PDF ↗ |
| K132472 | JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD | Justright Surgical, LLC | 2014-02-11 | Traditional | PDF ↗ |
| K133938 | ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY | Covidien | 2014-01-22 | Special | PDF ↗ |
Product code GDW · Class II · General, Plastic Surgery. Data: openFDA.