Clearance Summary
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) received FDA 510(k) clearance under submission number K190744, sponsored by Olympus Winter & Ibe GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2019-08-29.
- Submission: K190744
- Applicant / Sponsor: Olympus Winter & Ibe GmbH
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 2019-08-29
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.