Clearance Summary
OLYMPUS MH-246R BALLOON SHEATH received FDA 510(k) clearance under submission number K961048, sponsored by Olympus America, 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 1996-09-16.
- Submission: K961048
- Applicant / Sponsor: Olympus America, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1996-09-16
Classification & Regulation
This clearance is catalogued under FDA product code ODG and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.