FDA 510(k) Applications for Medical Device Product Code "GAG"
(Stapler, Surgical)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K232126 | Covidien | EEAÖCircular Stapler with Tri-StapleÖ Technology and OrVilÖ Transoral Circular Stapler Anvil | 08/16/2023 |
| K231934 | Covidien | GIAÖ Stapler with Tri-StapleÖ Technology | 10/27/2023 |
| K231491 | Covidien | TAÖ Stapler and Loading Unit with DST SeriesÖ Technology | 08/16/2023 |
| K221629 | Covidien | Tri-StapleÖ 2.0 Black Circular Reloads (for use with SigniaÖ Circular Adapters) | 02/22/2023 |
| K240881 | Covidien (Part of Medtronic) | SigniaÖ Circular Adapter (Standard Length) (SIGCIRSTND); SigniaÖ Circular Adapter XL Length (SIGCIRXL) | 11/01/2024 |
| K962258 | ETHICON ENDO-SURGERY, INC. | ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP | 09/11/1996 |
| K970079 | ETHICON ENDO-SURGERY, INC. | PROXIMATE DISPOSABLE SKIN STAPLER | 03/11/1997 |
| K241629 | Ethicon Endo-Surgery, LLC | 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 ( | 07/03/2024 |
| K213633 | Ethicon Endo-Surgery, LLC | ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler | 04/08/2022 |
| K243596 | Intuitive Surgical, Inc. | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | 03/10/2025 |
| K234039 | Lexington Medical, Inc. | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) | 05/07/2024 |
| K251482 | Lexington Medical, Inc. | AEONÖ Endoscopic Powered Stapler | 07/11/2025 |
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