Clearance Summary
High Flow Insufflation Unit (UHI-4) received FDA 510(k) clearance under submission number K243527, sponsored by Olympus Medical Systems Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2025-01-13.
- Submission: K243527
- Applicant / Sponsor: Olympus Medical Systems Corporation
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 2025-01-13
Classification & Regulation
This clearance is catalogued under FDA product code HIF and 21 CFR 884.1730, within the Obstetrics/Gynecology review panel as a Class II device.