Clearance Summary
CONVATEC FECAL MANAGEMENT SYSTEM received FDA 510(k) clearance under submission number K032734, sponsored by Convatec, A Bristol-Myers Squibb Co.. 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 2004-04-08.
- Submission: K032734
- Applicant / Sponsor: Convatec, A Bristol-Myers Squibb Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2004-04-08
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.