Clearance Summary
Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear received FDA 510(k) clearance under submission number K163492, sponsored by United States Endoscopy Group, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2017-01-06.
- Submission: K163492
- Applicant / Sponsor: United States Endoscopy Group, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2017-01-06
Classification & Regulation
This clearance is catalogued under FDA product code FDF and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.