Clearance Summary
ENTEROSCOPY OVERTUBE, MODEL 00712140 received FDA 510(k) clearance under submission number K100081, sponsored by United States Endoscopy Group, Inc.. 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 2010-04-12.
- Submission: K100081
- Applicant / Sponsor: United States Endoscopy Group, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2010-04-12
Classification & Regulation
This clearance is catalogued under FDA product code FED and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.