Clearance Summary
Liger Medical HTU-110 received FDA 510(k) clearance under submission number K152843, sponsored by Liger Medical, LLC. 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 2016-06-24.
- Submission: K152843
- Applicant / Sponsor: Liger Medical, LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4120
- Decision date: 2016-06-24
Classification & Regulation
This clearance is catalogued under FDA product code HGI and 21 CFR 884.4120, within the Obstetrics/Gynecology review panel as a Class II device.