# United States Surgical, A Division of Tyco Healthc

- Location (FDA's records): Norwalk, CT
- FDA decisions: 218 (1977–2007): 218 510(k) clearances
- Product codes: GCJ (30), GDW (28), FZP (17), GAM (12), HET (9), HAO (7), GAP (5), GEI (5), FTL (5), HRX (5), GAL (4), KWQ (4)
- Predicates its devices cite: 62 (31 its own); citations of its devices by later devices: 259 (31 its own)
- Recalls linked to its devices: 86 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smith & Nephew Richards, Inc.: 5 (https://510kreport.com/company/smith-nephew-richards)
- Smith & Nephew, Inc., Orthopaedic Div.: 4 (https://510kreport.com/company/smith-nephew-orthopaedic-div)
- Poly-Medics,Inc.: 2 (https://510kreport.com/company/poly-medics)
- Richards Medical Co., Inc.: 2 (https://510kreport.com/company/richards-medical)
- Biopsys Medical, Inc.: 2 (https://510kreport.com/company/biopsys-medical)
- Imagyn Medical, Inc.: 2 (https://510kreport.com/company/imagyn-medical)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- Unitedstates Surgical: 1 (https://510kreport.com/company/unitedstates-surgical)

## Firms that cite its devices most
- Covidien: 22 (https://510kreport.com/company/covidien)
- Covidien Lp, Formerly Registered AS United States: 11 (https://510kreport.com/company/covidien-lp-formerly-registered-as-united-states)
- Niti Medical Technologies, Ltd.: 7 (https://510kreport.com/company/niti-medical-technologies)
- Frankenman International Limited: 5 (https://510kreport.com/company/frankenman-international)
- Covidien, Formerly US Surgical A Divison of Tyco H: 5 (https://510kreport.com/company/covidien-formerly-us-surgical-a-divison-of-tyco-h)
- Surgical Devices, A Division of Tyco Healthcare: 5 (https://510kreport.com/company/surgical-devices-a-division-of-tyco-healthcare)
- Vanguard Medical Concepts, Inc.: 5 (https://510kreport.com/company/vanguard-medical-concepts)
- Aesculap, Inc.: 4 (https://510kreport.com/company/aesculap)

## Its most-cited devices
- K003709: Surgical Dynamics Mesh Cage System (2001), cited by 14
- K971680: Auto Suture Bone Wax (1997), cited by 8
- K062850: Autosuture Circular Eea Surgical Staplers (2006), cited by 8
- K061095: Auto Sutur Endo Gia Staplers (2006), cited by 7
- K903419: Modified Surgiport Disposable Trocar and Sleeve (1990), cited by 6
- K922123: Auto Suture Disposable Endoscopic Specimen Pouch (1993), cited by 6

## Recent decisions
- K071406: Autosuture Endo Clip Iii 5 MM Clip Applier (Nov 21, 2007)
- K071920: Autosuture Absorbable Tack and Applicator (Sep 28, 2007)
- K061288: Auto Suture Endo Clip Iii 5 MM Clip Applier (Nov 2, 2006)
- K062850: Autosuture Circular Eea Surgical Staplers (Oct 23, 2006)
- K062326: Autosuture Modified Versaport Trocar with Fixation Sleeve (Sep 1, 2006)
- K061095: Auto Sutur Endo Gia Staplers (May 31, 2006)
- K050947: Modification to: Modified Uss Polypropylene Suture (Jun 1, 2005)
- K042412: Modified Spacemaker System (Sep 24, 2004)

Source page: https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc