VITALA CONTINENCE CONTROL DEVICE— 510(k) K083785

Substantially Equivalent

Convatec

FDA 510(k) clearance K083785 for VITALA CONTINENCE CONTROL DEVICE, Substantially Equivalent on 2010-04-02. Applicant: Convatec.

Clearance details

Applicant: Convatec
Product code: Code EZQ
Advisory panel: Gastroenterology, Urology
Date received: 2008-12-19
Decision date: 2010-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skillman, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZQ

product code EZQ

Malfunction: 800
Other: 1
Total: 801

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.