SELFCATH— 510(k) K901738

Substantially Equivalent

Vitaid, Ltd.

FDA 510(k) clearance K901738 for SELFCATH, Substantially Equivalent on 1990-06-27. Applicant: Vitaid, Ltd..

Clearance details

Applicant: Vitaid, Ltd.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1990-04-17
Decision date: 1990-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewiston, NY, US

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Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.