510(k) K171336 · FAJ Cystoscope And Accessories, Flexible/Rigid
Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath
| Applicant | Henke-Sass, Wolf GmbH, Tuttlingen, DE |
| Decision | Substantially Equivalent, Dec 7, 2017 |
| Received | May 8, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171336
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.