Clearance Summary
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED received FDA 510(k) clearance under submission number K132389, sponsored by Daniel & Daniel Consulting. 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 2014-02-25.
- Submission: K132389
- Applicant / Sponsor: Daniel & Daniel Consulting
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2014-02-25
Classification & Regulation
This clearance is catalogued under FDA product code OWN and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.