Clearance Summary
TRAY, BLADDER IRRIGATION received FDA 510(k) clearance under submission number K760047, sponsored by M-C Ind., 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 1977-03-01.
- Submission: K760047
- Applicant / Sponsor: M-C Ind., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1977-03-01
Classification & Regulation
This clearance is catalogued under FDA product code EYN and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.