# Sutura, Inc.

- Location (FDA's records): Fountain Valley, CA
- FDA decisions: 5 (2000–2006): 5 510(k) clearances
- Product codes: GAW (4), OCW (1)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (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: 2 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Cardiothoracic Systems, Inc.: 1 (https://510kreport.com/company/cardiothoracic-systems)

## Its most-cited devices
- K994087: Superstitch (2000), cited by 1
- K012865: Superstitch Vascular Suturing Device (2001), cited by 1

## Recent decisions
- K062125: Superstitch 5F, 12F, and EL (Oct 19, 2006)
- K053482: Superstitch GW, Models 06-15-04-GW, 08-15-04-GW (Dec 27, 2005)
- K020940: Superstitch Vascular Suturing Device, 6 French, Models 06-15-00X; Mid-Length 06-25-00X (Apr 17, 2002)
- K012865: Superstitch Vascular Suturing Device (Sep 25, 2001)
- K994087: Superstitch (Mar 1, 2000)

Source page: https://510kreport.com/company/sutura