| 2026-05-11 |
K260196 |
Ethicon Endo-Surgery, LLC
|
ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm) |
| 2026-04-10 |
K253657 |
Covidien (Part of Medtronic)
|
Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads |
| 2025-12-17 |
K252739 |
Ethicon Endo-Surgery, LLC
|
ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T) |
| 2025-05-14 |
K250835 |
Ethicon Endo-Surgery, LLC
|
ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) |
| 2025-02-25 |
K243276 |
Ethicon Endo-Surgery, LLC
|
ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Stapler (GTX90); ECHELON LINEAR Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR Stapler 3D 90mm Green Reload (GTXR90G) |
| 2024-10-28 |
K241630 |
Ethicon Endo-Surgery, LLC
|
ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) |
| 2024-10-04 |
K242679 |
Fengh Medical Co., Ltd.
|
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series) |
| 2023-05-08 |
K222487 |
Anika Therapeutics, Inc.
|
Anika Tissue Tack Fixation System |
| 2023-04-21 |
K222210 |
Lexington Medical, Inc.
|
AEON Endoscopic Stapler |
| 2023-03-15 |
K223760 |
Ethicon Endo-Surgery
|
ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR Cutters 100mm Green Reload (GLCR100G) |
| 2023-01-19 |
K211197 |
Changzhou Waston Medical Appliance Co., Ltd.
|
Disposable Endoscopic Cutter Stapler and Cartridge |
| 2022-11-30 |
K221771 |
Covidien
|
EEA Circular Stapler with Tri-Staple Technology |
| 2022-11-29 |
K222641 |
Covidien
|
Signia Small Diameter Reloads Including Regular (Round) Tip Version |
| 2022-09-30 |
K221003 |
Covidien
|
Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA |
| 2022-05-05 |
K221013 |
Covidien
|
GIA Auto Suture Stapler with DST Series Technology |
| 2022-04-29 |
K221006 |
Covidien
|
GIA Stapler with Tri-Staple Technology |
| 2022-04-29 |
K221005 |
Covidien
|
EEA Circular Stapler with Tri-Staple Technology |
| 2022-03-03 |
K211811 |
Wuxi Beien Surgery Device Co., Ltd.
|
Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers |
| 2021-12-30 |
K211458 |
Ningbo Verykind Medical Device Co., Ltd.
|
Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers |
| 2021-10-01 |
K201934 |
Surgimatix, Inc.
|
Surgimatix Absorbable Fixation System |
| 2021-06-24 |
K210909 |
Ezisurg Medical Co., Ltd.
|
easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use |
| 2021-05-27 |
K201639 |
Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
|
Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads |
| 2021-05-18 |
K202709 |
Ningbo Verykind Medical Device Co., Ltd.
|
Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges |
| 2021-04-28 |
K210278 |
Standard Bariatrics
|
Titan SGS |
| 2021-02-05 |
K200320 |
M/s. Meril Endo Surgery Private Limited.
|
Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload |