NONABSORBABLE SILK SURGICAL SUTURE— 510(k) K904478

Substantially Equivalent for Some Indications

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K904478 for NONABSORBABLE SILK SURGICAL SUTURE, Substantially Equivalent for Some Indications on 1990-11-14. Applicant: United States Surgical, A Division of Tyco Healthc.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code GAP
Advisory panel: General, Plastic Surgery
Date received: 1990-09-28
Decision date: 1990-11-14
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAP

product code GAP

Death: 3
Injury: 491
Malfunction: 2,253
Total: 2,747

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.