510(k) K961605 ยท HIH Hysteroscope (And Accessories)
KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE
| Applicant | KARL STORZ Endoscopy-America, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, Nov 13, 1996 |
| Received | Apr 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961605
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2026 | Karl Storz Endoscopy Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1. Open, Classified |
HIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.