POLYVIOLENE SURGICL SUTURE— 510(k) K943949

Substantially Equivalent for Some Indications

Look, Inc.

FDA 510(k) clearance K943949 for POLYVIOLENE SURGICL SUTURE, Substantially Equivalent for Some Indications on 1994-11-10. Applicant: Look, Inc..

Clearance details

Applicant: Look, Inc.
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 1994-08-02
Decision date: 1994-11-10
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Ada, OK, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

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.