Clearance Summary
OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 received FDA 510(k) clearance under submission number K111425, sponsored by Olympus Medical Systems Corp.. 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 2012-04-20.
- Submission: K111425
- Applicant / Sponsor: Olympus Medical Systems Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 2012-04-20
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.