510(k) clearance
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)
- 510(k) number
- K254252
- Applicant
- Karl Storz SE & CO. KG
- Decision date
- Sep 25, 2026
- Date received
- Dec 29, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HIH
- Device type
- Hysteroscope (And Accessories)
- Device class
- Class II
- Regulation
- 21 CFR 884.1690
- Advisory committee
- Obstetrics/Gynecology
- Statement or summary
- Summary
- Third party
- N
- Location
- Tuttlingen, DE