Clearance Summary
CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS received FDA 510(k) clearance under submission number K951972, sponsored by Cabot Medical Corp.. 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 1995-07-21.
- Submission: K951972
- Applicant / Sponsor: Cabot Medical Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1995-07-21
Classification & Regulation
This clearance is catalogued under FDA product code FBO and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.