American Silk Sutures, Inc.
Ledyard, CT, US
American Silk Sutures, Inc. appears in FDA device records in Ledyard, CT. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for American Silk Sutures, Inc. between 1985 and 1992. The busiest year on record is 1987, with 8. The most recent is 1992, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 2 |
| 1987 | 8 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K922143 | AMERICAN BURN SHEET | KME | Substantially Equivalent | |
| K904514 | STRUNG TELFA NON-ADHERENT SPONGE | HBA | Substantially Equivalent | |
| K902921 | RAYON NEUROLOGICAL SPONGE | HBA | Substantially Equivalent | |
| K872810 | STRUNG DENTAL ROLLS | EFN | Substantially Equivalent | |
| K872951 | AMERICAN BRAIN RETRACTOR COVER | GET | Substantially Equivalent | |
| K872905 | AMERICAN NASAL SPONGE | EPP | Substantially Equivalent | |
| K872906 | SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE | GEA | Substantially Equivalent | |
| K872809 | GAUZE CHERRY SPONGE | GDY | Substantially Equivalent | |
| K872808 | CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8 | EFQ | Substantially Equivalent | |
| K872807 | NON-WOVEN TRACHEOTOMY SPONGE | GDY | Substantially Equivalent | |
| K872806 | STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG | EFQ | Substantially Equivalent | |
| K862494 | POLYESTER SPONGE PATTIE | HBA | Substantially Equivalent | |
| K854713 | COTTON NEUROLOGICAL SPONGE | HBA | Substantially Equivalent | |
| K854714 | X-RAY DETECTABLE COTTON BALLS | GDY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain