Clearance Summary
GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I received FDA 510(k) clearance under submission number K032177, sponsored by Olympus Opto-Electronics 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 2003-10-02.
- Submission: K032177
- Applicant / Sponsor: Olympus Opto-Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2003-10-02
Classification & Regulation
This clearance is catalogued under FDA product code FDS and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.