510(k) K191357 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
Flexible HD Cysto-Urethroscope System
| Applicant | KARL STORZ Endoscopy-America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Sep 18, 2019 |
| Received | May 21, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191357
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.