Clearance Summary
UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) received FDA 510(k) clearance under submission number K254252, sponsored by Karl Storz SE & CO. KG. 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 2026-09-25.
- Submission: K254252
- Applicant / Sponsor: Karl Storz SE & CO. KG
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1690
- Decision date: 2026-09-25
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.