CATGUT SUTURE CHROMIC— 510(k) K931919

Substantially Equivalent

Surgimetrics International, Ltd.

FDA 510(k) clearance K931919 for CATGUT SUTURE CHROMIC, Substantially Equivalent on 1994-03-03. Applicant: Surgimetrics International, Ltd..

Clearance details

Applicant: Surgimetrics International, Ltd.
Product code: Code GAL
Advisory panel: General, Plastic Surgery
Date received: 1993-04-16
Decision date: 1994-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAL

product code GAL

Malfunction: 681
Other: 1
Total: 682

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.