Clearance Summary
CONQUEST MALE CONTINENCE SYSTEM received FDA 510(k) clearance under submission number K942941, 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 1995-03-17.
- Submission: K942941
- Applicant / Sponsor: Convatec, A Bristol-Myers Squibb Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5250
- Decision date: 1995-03-17
Classification & Regulation
This clearance is catalogued under FDA product code EXJ and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class I device.