510(k) K233942 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Aug 1, 2024 |
| Received | Dec 14, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233942
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.