Clearance Summary
Sheath, Stopcock Accessory received FDA 510(k) clearance under submission number K213207, sponsored by Olympus Winter & Ibe GmbH. 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 2021-12-22.
- Submission: K213207
- Applicant / Sponsor: Olympus Winter & Ibe GmbH
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1690
- Decision date: 2021-12-22
Classification & Regulation
This clearance is catalogued under FDA product code HIH and 21 CFR 884.1690, within the Obstetrics/Gynecology review panel as a Class II device.