SCM-3 AND ACCESSORIES— 510(k) K914921

Name: FDA 510(k) clearance K914921
Creator: U.S. Food and Drug Administration
Published: 1992-03-12

Substantially Equivalent

Gaymar Industries, Inc.

FDA 510(k) clearance K914921 for SCM-3 AND ACCESSORIES, Substantially Equivalent on 1992-03-12. Applicant: Gaymar Industries, Inc.. Device class: 1.

Clearance details

Applicant: Gaymar Industries, Inc.
Product code: Code IKY
Device class: Class 1
Regulation: 21 CFR 880.5150
Advisory panel: General Hospital
Date received: 1991-11-04
Decision date: 1992-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orchard Park, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IKY

product code IKY

Death: 5
Malfunction: 491
Other: 4
Total: 500

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.