510(k) K261015 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Solo Scope Colonoscope System
| Applicant | Gi View, Ltd., Ramat Gan, IL |
| Decision | Substantially Equivalent, Aug 21, 2026 |
| Received | Mar 27, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261015
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.