Clearance Summary
UNIDRIVE SIII System received FDA 510(k) clearance under submission number K223520, sponsored by Karl Storz-Endoscopy-America, Inc.. 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 2023-04-27.
- Submission: K223520
- Applicant / Sponsor: Karl Storz-Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1690
- Decision date: 2023-04-27
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.