Clearance Summary
BELLA - VAC IRRIGATOR received FDA 510(k) clearance under submission number K874493, sponsored by Bel-Can Industries. 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 1988-02-05.
- Submission: K874493
- Applicant / Sponsor: Bel-Can Industries
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4370
- Decision date: 1988-02-05
Classification & Regulation
This clearance is catalogued under FDA product code KQT and 21 CFR 876.4370, within the Gastroenterology, Urology review panel as a Class II device.