510(k) K202365 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Pentax Medical Video Duodenoscope ED32-i10
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Apr 1, 2021 |
| Received | Aug 19, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202365
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.