Product code GAG
- Device name
- Stapler, Surgical
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 878.4740
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251482 | AEON™ Endoscopic Powered Stapler | Lexington Medical, Inc. | 2025-07-11 |
| K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | Intuitive Surgical, Inc. | 2025-03-10 |
| K240881 | Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) | Covidien (Part of Medtronic) | 2024-11-01 |
| 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 ... | Ethicon Endo-Surgery, LLC | 2024-07-03 |
| 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 |
| K231934 | GIA™ Stapler with Tri-Staple™ Technology | Covidien | 2023-10-27 |
| K231491 | TA™ Stapler and Loading Unit with DST Series™ Technology | Covidien | 2023-08-16 |
| K232126 | EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil | Covidien | 2023-08-16 |
| K221629 | Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) | Covidien | 2023-02-22 |
| K213633 | ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler | Ethicon Endo-Surgery, LLC | 2022-04-08 |
| K970079 | PROXIMATE DISPOSABLE SKIN STAPLER | Ethicon Endo-Surgery, Inc. | 1997-03-11 |
| K962258 | ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP | Ethicon Endo-Surgery, Inc. | 1996-09-11 |
| K934188 | DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART | Deroyal Industries, Inc. | 1994-03-28 |
| K934105 | DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES | Surgical Innovations Corp. | 1994-03-28 |
| K932476 | PROXIMATE RELOADABLE ARTICULATING LINEAR STAPLER | Ethicon Endo-Surgery, Inc. | 1993-12-01 |
| K933901 | REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) | Richard-Allan Medical | 1993-11-19 |
| K926127 | SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM | Life Medical Sciences, Inc. | 1993-06-24 |
| K892927 | PROXIMATE LINEAR CUTTER THICK TISSUE INST. | ETHICON, Inc. | 1989-05-26 |
| K884404 | HERNIASTAT | Innovative Surgical Devices Corp. | 1988-11-08 |
| K862772 | V. MUELLER (R) GOOSENECK CIRCULAR STAPLER | American V. Mueller | 1986-08-18 |
| K851258 | WECK LX TM SKIN STAPLER | Edward Weck, Inc. | 1985-06-07 |
| K851121 | PI-PHEUMO INTESTINAL INSTRUMENT SET | Surgeons Choice, Inc. | 1985-04-25 |
| K850947 | V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS | American V. Mueller | 1985-04-17 |
| K844417 | APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE | Davis & Geck, Inc. | 1984-12-17 |
| K844628 | V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET | American V. Mueller | 1984-12-14 |
| K840177 | APPOSE ULE STERILE DISPOS. SKIN STAP | Davis & Geck, Inc. | 1984-03-05 |
| K840178 | APPOSE DISPOS. SKIN STAPLER W/AUTO | Davis & Geck, Inc. | 1984-03-05 |
| K834138 | HYPO SUTURE | Medical Design & Manufacturing Corp. | 1984-01-27 |
| K830741 | PARAMETRIC STERILITY RELEASE OF AUTO | United Surgical Corp. | 1983-08-11 |
| K823776 | PI-PNEUMO-INTESTINAL INSTRUMENT SET | Surgeons Choice, Inc. | 1983-01-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10705036043546 | ETHICON | ETHICON ENDO-SURGERY, LLC | 2025-08-22 |
| 10705036043539 | ETHICON | ETHICON ENDO-SURGERY, LLC | 2025-08-22 |
| 10705036043522 | ETHICON | ETHICON ENDO-SURGERY, LLC | 2025-08-22 |
| 10705036027850 | Echelon Linear Cutter | ETHICON ENDO-SURGERY, LLC | 2024-04-15 |
| 10705036027867 | Echelon Linear Cutter | ETHICON ENDO-SURGERY, LLC | 2024-04-15 |
| 10705036027874 | Echelon Linear Cutter | ETHICON ENDO-SURGERY, LLC | 2024-04-15 |
| 10705036027881 | Echelon Linear Cutter | ETHICON ENDO-SURGERY, LLC | 2024-04-15 |
| 10705036027898 | Echelon Linear Cutter | ETHICON ENDO-SURGERY, LLC | 2024-04-15 |
| 10705036027904 | Echelon Linear Cutter | ETHICON ENDO-SURGERY, LLC | 2024-04-15 |
| 10705036030874 | Echelon Linear Cutter | ETHICON ENDO-SURGERY, LLC | 2024-04-15 |
| 10705036030881 | Echelon Linear Cutter | ETHICON ENDO-SURGERY, LLC | 2024-04-15 |
| 10705036030898 | Echelon Linear Cutter | ETHICON ENDO-SURGERY, LLC | 2024-04-15 |
| 10705036035015 | ECHELON | ETHICON ENDO-SURGERY, LLC | 2022-09-23 |
| 10705036035008 | ECHELON | ETHICON ENDO-SURGERY, LLC | 2022-09-23 |
| 10705036034995 | ECHELON | ETHICON ENDO-SURGERY, LLC | 2022-09-23 |
| 10705036034988 | ECHELON | ETHICON ENDO-SURGERY, LLC | 2022-09-23 |
| 10705036034971 | ECHELON | ETHICON ENDO-SURGERY, LLC | 2022-09-23 |
| 10705036034964 | ECHELON | ETHICON ENDO-SURGERY, LLC | 2022-09-23 |
| 10612479214801 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-07-16 |
| 10884521043107 | TA | Covidien LP | 2015-09-02 |
| 10884521043114 | TA | Covidien LP | 2015-09-02 |
| 10884521043121 | TA | Covidien LP | 2015-09-02 |
| 10884521043138 | TA | Covidien LP | 2015-09-02 |
| 10884521043145 | TA | Covidien LP | 2015-09-02 |
| 10884521043152 | TA | Covidien LP | 2015-09-02 |
| 10884521043169 | TA | Covidien LP | 2015-09-02 |
| 10884521031661 | GIA | Covidien LP | 2015-09-01 |
| 10884521031708 | GIA | Covidien LP | 2015-09-01 |
| 10884521033634 | GIA | Covidien LP | 2015-09-01 |
| 10884521033641 | GIA | Covidien LP | 2015-09-01 |