SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE— 510(k) K931914

Substantially Equivalent

Surgimetrics International, Ltd.

FDA 510(k) clearance K931914 for SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE, Substantially Equivalent on 1994-10-05. Applicant: Surgimetrics International, Ltd..

Clearance details

Applicant: Surgimetrics International, Ltd.
Product code: Code GAR
Advisory panel: General, Plastic Surgery
Date received: 1993-04-16
Decision date: 1994-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.