Clearance Summary
AMSURE BLADDER IRRIGATION SET received FDA 510(k) clearance under submission number K070873, sponsored by Amsino Intl., 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 2007-12-19.
- Submission: K070873
- Applicant / Sponsor: Amsino Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2007-12-19
Classification & Regulation
This clearance is catalogued under FDA product code LJH and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.