510(k) K161222 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
PENTAX MEDICAL ED-3490TK, Video Duodenoscope
| Applicant | Pentax Medical, Montvale NJ, US |
| Decision | Substantially Equivalent, Feb 7, 2018 |
| Received | Apr 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161222
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2018 | Pentax of America Inc Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420)
These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic ac Terminated |
FDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.