Clearance Summary
VITALA CONTINENCE CONTROL DEVICE received FDA 510(k) clearance under submission number K083785, sponsored by Convatec. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2010-04-02.
- Submission: K083785
- Applicant / Sponsor: Convatec
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5900
- Decision date: 2010-04-02
Classification & Regulation
This clearance is catalogued under FDA product code EZQ and 21 CFR 876.5900, within the Gastroenterology, Urology review panel as a Class I device.