# Tyco Healthcare Group LP

- Location (FDA's records): Mansfield, MA
- FDA decisions: 6 (2001–2008): 6 510(k) clearances
- Names in FDA's records: Tyco Healthcare Group LP (4); Tyco Healthcare Group (2)
- Product codes: FRO (1), GDW (1), GAM (1), NYU (1), GAW (1), FLL (1)
- Predicates its devices cite: 9 (0 its own); citations of its devices by later devices: 12 (0 its own)
- Recalls linked to its devices: 33 (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: 3 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)
- Synovis Surgical Innovations: 1 (https://510kreport.com/company/synovis-surgical-innovations)
- Kendall: 1 (https://510kreport.com/company/kendall)
- Medical Components, Inc.: 1 (https://510kreport.com/company/medical-components)
- Avecor Cardiovascular, Inc.: 1 (https://510kreport.com/company/avecor-cardiovascular)
- Intelligent Medical Systems: 1 (https://510kreport.com/company/intelligent-medical-systems)

## Firms that cite its devices most
- Covidien, Formerly US Surgical A Divison of Tyco H: 3 (https://510kreport.com/company/covidien-formerly-us-surgical-a-divison-of-tyco-h)
- Mediana Co., Ltd.: 1 (https://510kreport.com/company/mediana)
- Rochal Industries, LLC: 1 (https://510kreport.com/company/rochal-industries)
- Foosin Medical Supplies Inc., Ltd.: 1 (https://510kreport.com/company/foosin-medical-supplies)
- United States Surgical, A Division of Tyco Healthc: 1 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Covidien: 1 (https://510kreport.com/company/covidien)
- Kendall: 1 (https://510kreport.com/company/kendall)
- B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.: 1 (https://510kreport.com/company/bjzh-f-panther-medical-equipment)

## Its most-cited devices
- K080898: Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement (2008), cited by 4
- K071371: Copa Amd Antimicrobial Wound Dressing (2007), cited by 2
- K060509: Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating (2006), cited by 2
- K010909: Nonabsorbable Polypropylene Surgical Suture (2001), cited by 2
- K063536: Polysorb* Synthetic Absorbable Suture with Modified Packaging (2007), cited by 1
- K060649: Genius 2 Infrared Tympanic Electronic Thermometer, Model 303000 (2006), cited by 1

## Recent decisions
- K080898: Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement (May 5, 2008)
- K071371: Copa Amd Antimicrobial Wound Dressing (Nov 19, 2007)
- K063536: Polysorb* Synthetic Absorbable Suture with Modified Packaging (Jan 29, 2007)
- K060509: Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating (Jun 23, 2006)
- K060649: Genius 2 Infrared Tympanic Electronic Thermometer, Model 303000 (May 22, 2006)
- K010909: Nonabsorbable Polypropylene Surgical Suture (Apr 9, 2001)

Source page: https://510kreport.com/company/tyco-healthcare-group