510(k) K902872— NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE*

Substantially Equivalent for Some Indications

United States Surgical, A Division of Tyco Healthc

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code GAW
Advisory panel: General, Plastic Surgery
Date received: 1990-06-29
Decision date: 1990-09-27
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Norwalk, CT, US

Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.