# Covidien, Formerly US Surgical A Divison of Tyco H

- Location (FDA's records): North Haven, CT
- FDA decisions: 13 (2010–2013): 13 510(k) clearances
- Product codes: GDW (8), GCJ (3), GAM (1), KCT (1)
- Predicates its devices cite: 38 (9 its own); citations of its devices by later devices: 44 (9 its own)
- Recalls linked to its devices: 81 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- United States Surgical, A Division of Tyco Healthc: 5 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Covidien Lp, Formerly Registered AS United States: 5 (https://510kreport.com/company/covidien-lp-formerly-registered-as-united-states)
- Covidien: 3 (https://510kreport.com/company/covidien)
- Tyco Healthcare Group LP: 3 (https://510kreport.com/company/tyco-healthcare-group)
- Surgical Devices, Tyco Healthcare Group LP: 2 (https://510kreport.com/company/surgical-devices-tyco-healthcare-group)
- Surgical Devices, A Divsion of Tyco Healthcare: 2 (https://510kreport.com/company/surgical-devices-a-divsion-of-tyco-healthcare)
- Surgical Devices, A Global Business Unit Tyco: 2 (https://510kreport.com/company/surgical-devices-a-global-business-unit-tyco)
- Ethicon Endo-Surgery, Inc.: 2 (https://510kreport.com/company/ethicon-endo-surgery)

## Firms that cite its devices most
- Covidien: 19 (https://510kreport.com/company/covidien)
- Ezisurg Medical Co., Ltd.: 2 (https://510kreport.com/company/ezisurg-medical)
- Taiwan Surgical Corporation: 2 (https://510kreport.com/company/taiwan-surgical)
- Changzhou Kangdi Medical Stapler Co., Ltd.: 1 (https://510kreport.com/company/changzhou-kangdi-medical-stapler)
- Gordian Surgical, Ltd.: 1 (https://510kreport.com/company/gordian-surgical)
- Shinemed, LLC: 1 (https://510kreport.com/company/shinemed)
- Victor Medical Instruments Co., Ltd.: 1 (https://510kreport.com/company/victor-medical-instruments)
- Tgs Medical Co., Ltd.: 1 (https://510kreport.com/company/tgs-medical)

## Its most-cited devices
- K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers (2011), cited by 22
- K130435: Versaport V2 Bladeless Optical Trocar (2013), cited by 7
- K112349: Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar (2011), cited by 5
- K121510: Idrive Ultra Powered Handle Endo Gia Adapter (2012), cited by 3
- K103263: Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology (2010), cited by 2
- K130532: Idrive Ultra Sterilization Tray (2013), cited by 2

## Recent decisions
- K131705: Endo Gia Radial Reload with Tri-Staple Technology (Jul 1, 2013)
- K130532: Idrive Ultra Sterilization Tray (May 30, 2013)
- K130717: Endo Gia Reload (Apr 18, 2013)
- K130435: Versaport V2 Bladeless Optical Trocar (Mar 14, 2013)
- K122781: Reliamax Gastrointestinal Anastomosis and Reload (Feb 5, 2013)
- K123318: Idrive Ultra Powered Handle and Endo Gia Adapter (Dec 18, 2012)
- K121510: Idrive Ultra Powered Handle Endo Gia Adapter (Jul 25, 2012)
- K120061: Wound Protector (Mar 27, 2012)

Source page: https://510kreport.com/company/covidien-formerly-us-surgical-a-divison-of-tyco-h