510(k) K260649 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO);
| Applicant | Olympus Winter & Ibe GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, May 21, 2026 |
| Received | Feb 27, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260649
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.