# American Silk Sutures, Inc.

- Location (FDA's records): Lynn, MA
- FDA decisions: 14 (1985–1992): 14 510(k) clearances
- Product codes: HBA (4), GDY (3), EFQ (2), EPP (1), GEA (1), EFN (1), GET (1), KME (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 65 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- American Surgical Co., Inc.: 2 (https://510kreport.com/company/american-surgical)

## Its most-cited devices
- K862494: Polyester Sponge Pattie (1986), cited by 1
- K902921: Rayon Neurological Sponge (1990), cited by 1

## Recent decisions
- K922143: American Burn Sheet (Aug 10, 1992)
- K904514: Strung Telfa Non-Adherent Sponge (Mar 27, 1991)
- K902921: Rayon Neurological Sponge (Sep 18, 1990)
- K872810: Strung Dental Rolls (Dec 4, 1987)
- K872951: American Brain Retractor Cover (Sep 16, 1987)
- K872905: American Nasal Sponge (Sep 4, 1987)
- K872906: Suction Tube Tip Fits Over Bussie Frazier Tube (Aug 11, 1987)
- K872807: Non-Woven Tracheotomy Sponge (Aug 4, 1987)

Source page: https://510kreport.com/company/american-silk-sutures