# Ethicon Endo-Surgery, Inc.

- Location (FDA's records): Cincinnati, OH
- FDA decisions: 186 (1992–2026): 185 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Ethicon Endo-Surgery, Inc. (111); Ethicon Endo-Surgery, LLC (70); Ethicon Endo-Surgery (3); Ethicon Endo Surgery, Inc. (1); Ethicon Endo Surgery, LLC (1)
- Product codes: GDW (44), GCJ (31), LFL (29), GEI (26), OCW (11), KNW (7), GAG (5), FZP (4), GEX (4), OXC (3), HET (2), NEU (2)
- 510(k) review time since 2016: median 99 days, against 105 for FDA's reviews in the same codes and years (16 of 32 faster)
- Predicates its devices cite: 229 (145 its own); citations of its devices by later devices: 402 (145 its own)
- Recalls linked to its devices: 67 (18 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- ETHICON, Inc.: 20 (https://510kreport.com/company/ethicon)
- Ethicon Endo-Sugery, LLC: 7 (https://510kreport.com/company/ethicon-endo-sugery)
- Surgrx, Inc.: 6 (https://510kreport.com/company/surgrx)
- Indigo Medical, Inc.: 5 (https://510kreport.com/company/indigo-medical)
- Ultracision, Inc.: 5 (https://510kreport.com/company/ultracision)
- Valleylab, Inc.: 4 (https://510kreport.com/company/valleylab)
- United States Surgical, A Division of Tyco Healthc: 3 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Lsi Solutions: 3 (https://510kreport.com/company/lsi-solutions)

## Firms that cite its devices most
- Sterilmed, Inc.: 13 (https://510kreport.com/company/sterilmed)
- Stryker Sustainability Solutions: 10 (https://510kreport.com/company/stryker-sustainability-solutions)
- Vanguard Medical Concepts, Inc.: 10 (https://510kreport.com/company/vanguard-medical-concepts)
- Ezisurg Medical Co., Ltd.: 7 (https://510kreport.com/company/ezisurg-medical)
- Intuitive Surgical, Inc.: 5 (https://510kreport.com/company/intuitive-surgical)
- Ascent Healthcare Solutions: 5 (https://510kreport.com/company/ascent-healthcare-solutions)
- Tgs Medical Co., Ltd.: 5 (https://510kreport.com/company/tgs-medical)
- Golden Stapler Surgical Co., Ltd.: 5 (https://510kreport.com/company/golden-stapler-surgical)

## Its most-cited devices
- K032676: Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar (2003), cited by 26
- K020779: Proximate and Endopath Linear Cutters and Staplers (2002), cited by 20
- K984240: Endopath Endoscopic Instruments (1999), cited by 13
- K070887: Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and Staplers (and Reloads) (2007), cited by 11
- K060245: Harmonic Scalpel Blades and Shears (2006), cited by 10
- K002906: Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07 (2000), cited by 10

## Recent decisions
- K254196: HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (Sep 17, 2026)
- K260196: 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) (May 11, 2026)
- K252906: ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) (Jan 9, 2026)
- K252739: 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) (Dec 17, 2025)
- K250835: 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) (May 14, 2025)
- K243276: 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) (Feb 25, 2025)
- K241630: 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) (Oct 28, 2024)
- 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 Long Stapler  (ECH60L) (Jul 3, 2024)

Source page: https://510kreport.com/company/ethicon-endo-surgery