Clearance Summary
OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE received FDA 510(k) clearance under submission number K032092, sponsored by Olympus Optical Co., Ltd.. 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 2003-07-16.
- Submission: K032092
- Applicant / Sponsor: Olympus Optical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1075
- Decision date: 2003-07-16
Classification & Regulation
This clearance is catalogued under FDA product code FCL and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class I device.