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 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K133499 | SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA | Suzhou Beinuo Medical Equipment Co. , Ltd. | 2014-01-14 | Traditional | PDF ↗ |
| K132669 | PROXIFAST ABSORBABLE STAPLE | Surgimatix, Inc. | 2014-01-13 | Traditional | PDF ↗ |
| K133762 | ENDO GIA(TM) EXTRA LONG ADAPTER | Covidien, LLC | 2014-01-08 | Special | PDF ↗ |
| K132581 | MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE | Cardica, Inc. | 2014-01-07 | Traditional | PDF ↗ |
| K130738 | ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS | Nanjing Maidixin Medical Device Co., Ltd. | 2013-12-13 | Traditional | PDF ↗ |
| K132134 | OPTIFIX ABSORBABLE FIXATION SYSTEM | C.R. Bard, Inc. | 2013-12-02 | Traditional | PDF ↗ |
| K132493 | ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY | Covidien, LLC | 2013-10-23 | Special | PDF ↗ |
| K131663 | ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK | Ethicon Endo-Surgery, LLC | 2013-10-18 | Traditional | PDF ↗ |
| K131637 | ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) | Rotation Medical, Inc. | 2013-07-12 | Traditional | PDF ↗ |
| K131511 | DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR | Changzhou Sinolinks Medical Innovation Co., Ltd. | 2013-07-05 | Traditional | PDF ↗ |
| K131705 | ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY | Covidien, Formerly US Surgical A Divison of Tyco H | 2013-07-01 | Special | PDF ↗ |
| K131303 | DISPOSABLE CIRCULAR STAPLER | Changzhou City Zhiye Medical Devices Institute Co. | 2013-06-11 | Traditional | PDF ↗ |
| K130717 | ENDO GIA RELOAD | Covidien, Formerly US Surgical A Divison of Tyco H | 2013-04-18 | Special | PDF ↗ |
| K130653 | ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU | Ethicon Endo-Surgery, LLC | 2013-03-29 | Special | PDF ↗ |
| K123114 | ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE | ETHICON, Inc. | 2013-02-05 | Traditional | PDF ↗ |
| K122781 | RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD | Covidien, Formerly US Surgical A Divison of Tyco H | 2013-02-05 | Traditional | PDF ↗ |
| K123718 | PERMASORB DISPOSABLE FIXATION DEVICE | C.R. Bard, Inc. | 2013-01-22 | Special | PDF ↗ |
| K123318 | IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER | Covidien, Formerly US Surgical A Divison of Tyco H | 2012-12-18 | Special | PDF ↗ |
| K123109 | ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE | Covidien | 2012-10-23 | Special | PDF ↗ |
| K121510 | IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER | Covidien, Formerly US Surgical A Divison of Tyco H | 2012-07-25 | Traditional | PDF ↗ |
| K121600 | ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE | Ethicon Endo-Surgery, LLC | 2012-07-16 | Traditional | PDF ↗ |
| K121474 | DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER | Changzhou Kangdi Medical Stapler Co., Ltd. | 2012-07-16 | Traditional | PDF ↗ |
| K120179 | REACH SURGICAL STAPLERS | Reach Surgical, Inc. | 2012-05-23 | Traditional | PDF ↗ |
| K120373 | INSORB ABSORBALBE STAPLE | Incisive Surgical, Inc. | 2012-03-16 | Special | PDF ↗ |
| K120258 | DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS | Covidien, Formerly US Surgical A Divison of Tyco H | 2012-02-29 | Traditional | PDF ↗ |
| K120268 | AMID STAPLER | Safestich Medical, LLC | 2012-02-10 | Special | PDF ↗ |
| K112056 | ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL | Ethicon Endo-Surgery, LLC | 2011-12-19 | Traditional | PDF ↗ |
| K111825 | ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS | Covidien, Formerly US Surgical A Divison of Tyco H | 2011-10-25 | Traditional | PDF ↗ |
| K111195 | VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS | Ethicon Endo-Surgery, Inc. | 2011-08-03 | Traditional | PDF ↗ |
| K111111 | ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO | Ethicon Endo-Surgery, LLC | 2011-06-08 | Traditional | PDF ↗ |
| K110728 | IMESH TACKER | Easylap , Ltd. | 2011-06-08 | Traditional | PDF ↗ |
| K111153 | SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM | C.R. Bard, Inc. | 2011-05-24 | Special | PDF ↗ |
| K111064 | TIGERPAW SYSTEM II | Laax, Inc. | 2011-05-18 | Special | PDF ↗ |
| K103672 | REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET | Ethicon Endo-Surgery, LLC | 2011-04-08 | Traditional | PDF ↗ |
| K110385 | ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER | Ethicon Endo-Surgery, Inc. | 2011-03-25 | Traditional | PDF ↗ |
| K110049 | REUSABLE LINEAR STAPLER HANDLE | Ethicon Endo-Surgery, LLC | 2011-02-10 | Traditional | PDF ↗ |
| K103470 | PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2011-01-11 | Traditional | PDF ↗ |
| K103263 | ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY | Covidien, Formerly US Surgical A Divison of Tyco H | 2010-11-22 | Special | PDF ↗ |
| K101961 | TIGERPAW SYSTEM | Laax, Inc. | 2010-10-29 | Traditional | PDF ↗ |
| K102325 | IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010-10-13 | Traditional | PDF ↗ |
| K102632 | ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER | Ethicon Endo-Surgery, Inc. | 2010-10-07 | Traditional | PDF ↗ |
| K102291 | COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY | Covidien | 2010-09-15 | Traditional | PDF ↗ |
| K101378 | FRANKENMAN SURGICAL STAPLERS | Suzhou Frankenman Medical Equipment Co., Ltd. | 2010-06-29 | Traditional | PDF ↗ |
| K101444 | AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY | Surgical Devices, A Global Business Unit Tyco | 2010-06-14 | Special | PDF ↗ |
| K100723 | DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5 | Changzhou Kangdi Medical Stapler Co., Ltd. | 2010-04-30 | Traditional | PDF ↗ |
| K093845 | ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 | ETHICON, Inc. | 2010-04-07 | Traditional | PDF ↗ |
| K100386 | DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 | Changzhou Waston Medical Appliance Co., Ltd. | 2010-03-01 | Traditional | PDF ↗ |
| K092483 | BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018 | C.R. Bard, Inc. | 2009-12-18 | Traditional | PDF ↗ |
| K093410 | AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY | Surgical Devices, A Divsion of Tyco Healthcare | 2009-11-12 | Special | PDF ↗ |
| K093402 | AUTOSUTURE EEA ORVIL | Surgical Devices, A Global Business Unit Tyco | 2009-11-12 | Special | PDF ↗ |
| K093253 | AMID STAPLER | Safestitch, LLC | 2009-11-12 | Traditional | PDF ↗ |
| K092577 | ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75) | Ethicon Endo-Surgery, LLC | 2009-09-15 | Traditional | PDF ↗ |
| K091900 | ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE | Covidien Lp, Formerly Registered AS United States | 2009-07-16 | Special | PDF ↗ |
| K090821 | CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L | Frankenman International Limited | 2009-06-10 | Traditional | PDF ↗ |
| K091322 | CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G | Ethicon Endo-Surgery, Inc. | 2009-06-01 | Traditional | PDF ↗ |
| K091215 | INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT | Power Medical Interventions, Inc. | 2009-05-18 | Special | PDF ↗ |
| K083519 | AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS | Covidien Lp, Formerly Registered AS United States | 2009-04-10 | Traditional | PDF ↗ |
| K090159 | INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES | Incisive Surgical, Inc. | 2009-02-06 | Special | PDF ↗ |
| K083781 | EEA HEMORRHOID STAPLER & ACCESSORIES | Surgical Devices, A Global Business Unit Covidien | 2009-02-04 | Traditional | PDF ↗ |
| K082396 | DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087 | C.R. Bard, Inc. | 2009-01-02 | Traditional | PDF ↗ |
| K083527 | INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS | Power Medical Interventions, Inc. | 2008-12-18 | Special | PDF ↗ |
| K071023 | REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C | Reach Surgical, Inc. | 2008-08-28 | Traditional | PDF ↗ |
| K081826 | INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V | Power Medical Interventions, Inc. | 2008-07-25 | Special | PDF ↗ |
| K080972 | ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP | Ethicon Endo-Sugery, LLC | 2008-07-03 | Traditional | PDF ↗ |
| K081146 | ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT) | Ethicon Endo-Surgery, LLC | 2008-06-26 | Traditional | PDF ↗ |
| K080839 | ECHELON GRAY CARTRIDGE, MODEL ERC45M | Ethicon Endo-Surgery, LLC | 2008-05-21 | Traditional | PDF ↗ |
| K080898 | AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT | Tyco Healthcare Group LP | 2008-05-05 | Traditional | PDF ↗ |
| K073001 | IDRIVES, IDRIVEC, IDRIVEF | Power Medical Interventions, Inc. | 2007-12-18 | Special | PDF ↗ |
| K073148 | IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS | Power Medical Interventions, Inc. | 2007-12-07 | Special | PDF ↗ |
| K071920 | AUTOSUTURE ABSORBABLE TACK AND APPLICATOR | United States Surgical, A Division of Tyco Healthc | 2007-09-28 | Traditional | PDF ↗ |
| K071708 | I45, I45S, I60, AND I60S | Power Medical Interventions, Inc. | 2007-09-27 | Traditional | PDF ↗ |
| K070887 | ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS) | Ethicon Endo-Surgery, LLC | 2007-05-25 | Traditional | PDF ↗ |
| K071061 | ABSORBATACK AND APPLICATOR | Sorbx, LLC | 2007-05-16 | Traditional | PDF ↗ |
| K062869 | CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G | Ethicon Endo-Surgery, LLC | 2007-02-26 | Traditional | PDF ↗ |
| K063746 | POWER EXTENDERS MODEL# PEC200, PES200,PES200S | Power Medical Interventions, Inc. | 2007-01-12 | Special | PDF ↗ |
| K063075 | NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS | Power Medical Interventions, Inc. | 2006-11-02 | Special | PDF ↗ |
| K062850 | AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS | United States Surgical, A Division of Tyco Healthc | 2006-10-23 | Special | PDF ↗ |
| K061649 | POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH | Power Medical Interventions, Inc. | 2006-09-01 | Special | PDF ↗ |
| K061784 | INSORB ABSORBABLE STAPLE, MODEL 1020 | Incisive Surgical, Inc. | 2006-07-26 | Special | PDF ↗ |
| K061156 | ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS | Ethicon Endo-Surgery, Inc. | 2006-07-03 | Traditional | PDF ↗ |
| K060494 | EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM | Medchannel, LLC | 2006-07-03 | Traditional | PDF ↗ |
| K061095 | AUTO SUTUR ENDO GIA STAPLERS | United States Surgical, A Division of Tyco Healthc | 2006-05-31 | Traditional | PDF ↗ |
| K053631 | CONTOUR TRANSTAR CURVED CUTTER STAPLER SET | Ethicon Endo-Surgery, Inc. | 2006-01-30 | Traditional | PDF ↗ |
| K052910 | POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS | Power Medical Interventions, Inc. | 2005-11-07 | Special | PDF ↗ |
| K052415 | POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS | Power Medical Interventions, Inc. | 2005-09-29 | Special | PDF ↗ |
| K051301 | PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES | Ethicon Endo-Surgery, Inc. | 2005-08-30 | Traditional | PDF ↗ |
| K051848 | SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 | Davol Inc., Sub. C. R. Bard, Inc. | 2005-08-11 | Traditional | PDF ↗ |
| K050610 | SALUTE FIXATION SYSTEM | Davol Inc., Sub. C. R. Bard, Inc. | 2005-05-25 | Traditional | PDF ↗ |
| K051002 | ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER | Ethicon Endo-Surgery, Inc. | 2005-05-17 | Traditional | PDF ↗ |
| K042492 | HAND STC, MODEL 60MM | Niti Medical Technologies , Ltd. | 2004-10-19 | Traditional | PDF ↗ |
| K041159 | JMS ABSORBABLE ANCHOR AND APPLICATOR | Jms, Inc. | 2004-07-27 | Traditional | PDF ↗ |
| K041331 | BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER | Biopsy Sciences, LLC | 2004-06-15 | Traditional | PDF ↗ |
| K040720 | SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM | Power Medical Interventions, Inc. | 2004-06-03 | Traditional | PDF ↗ |
| K041201 | ULTRACLIP II MR | Inrad | 2004-06-03 | Special | PDF ↗ |
| K040109 | HEMORRHAGE OCCLUDER PIN | Tools For Surgery, LLC | 2004-03-25 | Traditional | PDF ↗ |
| K040398 | SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS | Power Medical Interventions, Inc. | 2004-03-24 | Traditional | PDF ↗ |
| K040024 | SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29 | Power Medical Interventions, Inc. | 2004-02-04 | Special | PDF ↗ |
| K040038 | CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G | Ethicon Endo-Surgery, Inc. | 2004-02-04 | Traditional | PDF ↗ |
| K032973 | REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS | Vanguard Medical Concepts, Inc. | 2003-12-18 | Traditional | PDF ↗ |
| K033602 | INSORB ABSORBABLE STAPLE, MODEL SP-B20 | Incisive Surgical, Inc. | 2003-12-16 | Special | PDF ↗ |
Product code GDW · Class II · General, Plastic Surgery. Data: openFDA.