510(k) K254252 · HIH Hysteroscope (And Accessories)
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)
| Applicant | Karl Storz SE & CO. KG, Tuttlingen, DE |
| Decision | Substantially Equivalent, Sep 25, 2026 |
| Received | Dec 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254252
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.