STAINLESS STEEL SUTURE— 510(k) K931915

Name: FDA 510(k) clearance K931915
Creator: U.S. Food and Drug Administration
Published: 1994-03-03

Substantially Equivalent

Surgimetrics International, Ltd.

FDA 510(k) clearance K931915 for STAINLESS STEEL SUTURE, Substantially Equivalent on 1994-03-03. Applicant: Surgimetrics International, Ltd.. Device class: 2.

Clearance details

Applicant: Surgimetrics International, Ltd.
Product code: Code GAQ
Device class: Class 2
Regulation: 21 CFR 878.4495
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 ↗

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More clearances from Surgimetrics International, Ltd.

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K931914 — SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE1994-10-05
K931913 — SUTURE NON-ABSORBABLE SILK1994-03-03
K931916 — SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER1994-03-03
K931917 — SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE1994-03-03
K931918 — CATGUT SUTURE PLAIN1994-03-03

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.