UCB— 510(k) K950689

Substantially Equivalent

Cox Medical Ent., Inc.

FDA 510(k) clearance K950689 for UCB, Substantially Equivalent on 1995-03-06. Applicant: Cox Medical Ent., Inc..

Clearance details

Applicant: Cox Medical Ent., Inc.
Product code: Code MNL
Advisory panel: Gastroenterology, Urology
Date received: 1995-02-14
Decision date: 1995-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNL

product code MNL

Malfunction: 443
Total: 443

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.