SURGICAL SAW BLADES— 510(k) K934603

Name: FDA 510(k) clearance K934603
Creator: U.S. Food and Drug Administration
Published: 1994-02-22

Substantially Equivalent

American Medical Specialties, Inc.

FDA 510(k) clearance K934603 for SURGICAL SAW BLADES, Substantially Equivalent on 1994-02-22. Applicant: American Medical Specialties, Inc.. Device class: 1.

Clearance details

Applicant: American Medical Specialties, Inc.
Product code: Code GFA
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1993-09-24
Decision date: 1994-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GFA

product code GFA

Death: 2
Injury: 140
Malfunction: 2,337
Total: 2,479

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.