Clearance Summary
SUR-FIT UROSTOMY POUCH & URINARY BAG received FDA 510(k) clearance under submission number K800495, sponsored by E. R. Squibb & Sons, Inc.. 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 1980-04-08.
- Submission: K800495
- Applicant / Sponsor: E. R. Squibb & Sons, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5900
- Decision date: 1980-04-08
Classification & Regulation
This clearance is catalogued under FDA product code EXB and 21 CFR 876.5900, within the Gastroenterology, Urology review panel as a Class I device.