510(k) K181977 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
WiScope Digital Endoscope System
| Applicant | OTU Medical, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Aug 14, 2018 |
| Received | Jul 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181977
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.