Clearance Summary
PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 received FDA 510(k) clearance under submission number K960949, sponsored by Bristol-Myers Squibb. 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 1996-04-19.
- Submission: K960949
- Applicant / Sponsor: Bristol-Myers Squibb
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5250
- Decision date: 1996-04-19
Classification & Regulation
This clearance is catalogued under FDA product code KNX and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class II device.