FORMACLEAR- & MULTIPLE— 510(k) K842131

Name: FDA 510(k) clearance K842131
Creator: U.S. Food and Drug Administration
Published: 1984-09-10

Substantially Equivalent

Rna Medical Corp.

FDA 510(k) clearance K842131 for FORMACLEAR- & MULTIPLE, Substantially Equivalent on 1984-09-10. Applicant: Rna Medical Corp.. Device class: 2.

Clearance details

Applicant: Rna Medical Corp.
Product code: Code FKQ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1984-05-30
Decision date: 1984-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FKQ

product code FKQ

Other: 1
Total: 1

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.