Clearance Summary
XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE received FDA 510(k) clearance under submission number K031256, 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 2003-07-23.
- Submission: K031256
- 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: 2003-07-23
Classification & Regulation
This clearance is catalogued under FDA product code FDA and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.