510(k) K192245 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Pentax Medical Video Duodenoscope ED34-i10T2
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Nov 15, 2019 |
| Received | Aug 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192245
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2021 | Pentax of America Inc Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic Terminated |
FDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.