Clearance Summary
PROSYS BEDSIDE DRAINAGE BAG received FDA 510(k) clearance under submission number K953767, sponsored by Convatec, A Division of E.R. Squibb & Sons. 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 1995-12-20.
- Submission: K953767
- Applicant / Sponsor: Convatec, A Division of E.R. Squibb & Sons
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5250
- Decision date: 1995-12-20
Classification & Regulation
This clearance is catalogued under FDA product code FAQ and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class I device.