GAG — Stapler, Surgical Class II
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 |
|---|---|---|---|
| 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 |
| K231491 | covidien | TA Stapler and Loading Unit with DST Series Technology | August 16, 2023 |
| K232126 | covidien | EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular S | 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 |
| K934188 | deroyal industries | DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART | March 28, 1994 |
| K934105 | surgical innovations | DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES | 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 |
| K862772 | american v. mueller | V. MUELLER (R) GOOSENECK CIRCULAR STAPLER | August 18, 1986 |