OMEGASCOPE— 510(k) K924228

Substantially Equivalent

Omega Universal Technologies, Ltd.

FDA 510(k) clearance K924228 for OMEGASCOPE, Substantially Equivalent on 1993-02-26. Applicant: Omega Universal Technologies, Ltd..

Clearance details

Applicant: Omega Universal Technologies, Ltd.
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 1992-08-21
Decision date: 1993-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, NJ, US

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Adverse events under product code FBN

product code FBN

Death: 8
Malfunction: 951
Total: 959

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.