Clearance Summary
OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE received FDA 510(k) clearance under submission number K982733, sponsored by The Olympus Optical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1998-10-28.
- Submission: K982733
- Applicant / Sponsor: The Olympus Optical Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 1998-10-28
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.