STAINLESS STEEL SUTURE— 510(k) K931915

Substantially Equivalent

Surgimetrics International, Ltd.

FDA 510(k) clearance K931915 for STAINLESS STEEL SUTURE, Substantially Equivalent on 1994-03-03. Applicant: Surgimetrics International, Ltd..

Clearance details

Applicant: Surgimetrics International, Ltd.
Product code: Code GAQ
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

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Adverse events under product code GAQ

product code GAQ

Death: 3
Malfunction: 522
Total: 525

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.