Clearance Summary
PROSYS SAMEC LA received FDA 510(k) clearance under submission number K963265, 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 1996-10-25.
- Submission: K963265
- 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: 1996-10-25
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.