GAG — Stapler, Surgical Class II
FDA product code GAG covers "Stapler, Surgical", a Class II medical device regulated under 21 CFR 878.4740. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GAG
- Device Class
- Class II
- Regulation Number
- 878.4740
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General Hospital
- Implant
- No
Definition
A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253527 | covidien | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple | July 1, 2026 |
| K251482 | lexington medical | AEON Endoscopic Powered Stapler | July 11, 2025 |
| K243596 | intuitive surgical | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | March 10, 2025 |
| K240881 | covidien (part of medtronic) | Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapte | November 1, 2024 |
| K241629 | ethicon endo-surgery | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler | July 3, 2024 |
| K234039 | lexington medical | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler | May 7, 2024 |
| K231934 | covidien | GIA Stapler with Tri-Staple Technology | October 27, 2023 |
| K232126 | covidien | EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular S | August 16, 2023 |
| K231491 | covidien | TA Stapler and Loading Unit with DST Series Technology | August 16, 2023 |
| K221629 | covidien | Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) | February 22, 2023 |
| K213633 | ethicon endo-surgery | ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler | April 8, 2022 |
| K970079 | ethicon endo-surgery | PROXIMATE DISPOSABLE SKIN STAPLER | March 11, 1997 |
| K962258 | ethicon endo-surgery | ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP | September 11, 1996 |
| K934105 | surgical innovations | DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES | March 28, 1994 |
| K934188 | deroyal industries | DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART | March 28, 1994 |
| K932476 | ethicon endo-surgery | PROXIMATE RELOADABLE ARTICULATING LINEAR STAPLER | December 1, 1993 |
| K933901 | richard-allan medical | REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) | November 19, 1993 |
| K926127 | life medical sciences | SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM | June 24, 1993 |
| K892927 | ethicon | PROXIMATE LINEAR CUTTER THICK TISSUE INST. | May 26, 1989 |
| K884404 | innovative surgical devices | HERNIASTAT | November 8, 1988 |