FDA Product Code
FDA Product Code GAG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 878.4740
510(k) Clearances — 43 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253527 | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | Covidien, LLC | 2026-07-01 | Traditional | PDF ↗ |
| K251482 | AEON Endoscopic Powered Stapler | Lexington Medical, Inc. | 2025-07-11 | Traditional | PDF ↗ |
| K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | Intuitive Surgical, Inc. | 2025-03-10 | Traditional | PDF ↗ |
| K240881 | Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL) | Covidien (Part of Medtronic) | 2024-11-01 | Traditional | PDF ↗ |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) | Ethicon Endo-Surgery, LLC | 2024-07-03 | Special | PDF ↗ |
| K234039 | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) | Lexington Medical, Inc. | 2024-05-07 | Traditional | PDF ↗ |
| K231934 | GIA Stapler with Tri-Staple Technology | Covidien | 2023-10-27 | Traditional | PDF ↗ |
| K232126 | EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil | Covidien | 2023-08-16 | Special | PDF ↗ |
| K231491 | TA Stapler and Loading Unit with DST Series Technology | Covidien | 2023-08-16 | Traditional | PDF ↗ |
| K221629 | Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) | Covidien | 2023-02-22 | Traditional | PDF ↗ |
| K213633 | ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler | Ethicon Endo-Surgery, LLC | 2022-04-08 | Traditional | PDF ↗ |
| K970079 | PROXIMATE DISPOSABLE SKIN STAPLER | Ethicon Endo-Surgery, Inc. | 1997-03-11 | Traditional | PDF ↗ |
| K962258 | ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP | Ethicon Endo-Surgery, Inc. | 1996-09-11 | Traditional | PDF ↗ |
| K934188 | DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART | Deroyal Industries, Inc. | 1994-03-28 | Traditional | PDF ↗ |
| K934105 | DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES | Surgical Innovations Corp. | 1994-03-28 | Traditional | PDF ↗ |
| K932476 | PROXIMATE RELOADABLE ARTICULATING LINEAR STAPLER | Ethicon Endo-Surgery, Inc. | 1993-12-01 | Traditional | PDF ↗ |
| K933901 | REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) | Richard-Allan Medical | 1993-11-19 | Traditional | PDF ↗ |
| K926127 | SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM | Life Medical Sciences, Inc. | 1993-06-24 | Traditional | PDF ↗ |
| K892927 | PROXIMATE LINEAR CUTTER THICK TISSUE INST. | ETHICON, Inc. | 1989-05-26 | Traditional | PDF ↗ |
| K884404 | HERNIASTAT | Innovative Surgical Devices Corp. | 1988-11-08 | Traditional | PDF ↗ |
| K862772 | V. MUELLER (R) GOOSENECK CIRCULAR STAPLER | American V. Mueller | 1986-08-18 | Traditional | PDF ↗ |
| K851258 | WECK LX TM SKIN STAPLER | Edward Weck, Inc. | 1985-06-07 | Traditional | PDF ↗ |
| K851121 | PI-PHEUMO INTESTINAL INSTRUMENT SET | Surgeons Choice, Inc. | 1985-04-25 | Traditional | PDF ↗ |
| K850947 | V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS | American V. Mueller | 1985-04-17 | Traditional | PDF ↗ |
| K844417 | APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE | Davis & Geck, Inc. | 1984-12-17 | Traditional | PDF ↗ |
| K844628 | V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET | American V. Mueller | 1984-12-14 | Traditional | PDF ↗ |
| K840177 | APPOSE ULE STERILE DISPOS. SKIN STAP | Davis & Geck, Inc. | 1984-03-05 | Traditional | PDF ↗ |
| K840178 | APPOSE DISPOS. SKIN STAPLER W/AUTO | Davis & Geck, Inc. | 1984-03-05 | Traditional | PDF ↗ |
| K834138 | HYPO SUTURE | Medical Design & Manufacturing Corp. | 1984-01-27 | Traditional | PDF ↗ |
| K830741 | PARAMETRIC STERILITY RELEASE OF AUTO | United Surgical Corp. | 1983-08-11 | Traditional | PDF ↗ |
| K823776 | PI-PNEUMO-INTESTINAL INSTRUMENT SET | Surgeons Choice, Inc. | 1983-01-14 | Traditional | PDF ↗ |
| K820811 | PROXIMATE DISPOSABLE SKIN STAPLERS | ETHICON, Inc. | 1982-08-20 | Traditional | PDF ↗ |
| K821228 | DEKNATEL SKIN STAPLE EXTRACTOR | Howmedica Corp. | 1982-05-14 | Traditional | PDF ↗ |
| K813170 | ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER | Surgeons Choice, Inc. | 1982-02-12 | Traditional | PDF ↗ |
| K811030 | APPOSE SKIN STAPLER | Davis & Geck, Inc. | 1981-05-27 | Traditional | PDF ↗ |
| K803038 | PROXIMATE*II DISPOSABLE SKIN STAPLER | ETHICON, Inc. | 1980-12-30 | Traditional | PDF ↗ |
| K802611 | AUTO SUTURE DISPOS., EEA SURG. STAPLER | U. S. Surgical Corp. | 1980-11-12 | Traditional | PDF ↗ |
| K801445 | SKIN STAPLER HANDLE 523700/CARTRIDGES | Edward Weck, Inc. | 1980-07-14 | Traditional | PDF ↗ |
| K771619 | PROXIMATE DISP. SKIN STAPLER | ETHICON, Inc. | 1977-11-15 | Traditional | PDF ↗ |
| K771177 | SURGICAL STAPLING INSTRU., AUTO, SUTURE | United States Surgical, A Division of Tyco Healthc | 1977-10-18 | Traditional | PDF ↗ |
| K771113 | AUTO SUTURE R CLIP INSTRUMENT | United States Surgical, A Division of Tyco Healthc | 1977-09-30 | Traditional | PDF ↗ |
| K760732 | SKIN STAPLING INSTRUMENT | ETHICON, Inc. | 1976-11-03 | Traditional | PDF ↗ |
| K760733 | SKIN STAPLE EXTRACTOR | ETHICON, Inc. | 1976-11-03 | Traditional | PDF ↗ |
Product code GAG · Class II · General Hospital. Data: openFDA.