K981128

Substantially Equivalent

SOFSILK SUTURE

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: GAP
Advisory panel: General, Plastic Surgery
Date received: 1998-03-30
Decision date: 1998-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

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.