ENDOWASH— 510(k) K915620

Substantially Equivalent

Novar Medical Industries

FDA 510(k) clearance K915620 for ENDOWASH, Substantially Equivalent on 1993-12-02. Applicant: Novar Medical Industries.

Clearance details

Applicant: Novar Medical Industries
Product code: Code FEB
Advisory panel: Gastroenterology, Urology
Date received: 1991-11-25
Decision date: 1993-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: W. Orange, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

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.