510(k) K092710 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
PENTAX ED-3490TK, VIDEO DUODENOSCOPE
| Applicant | Pentax Medical Company, Montvale NJ, US |
| Decision | Substantially Equivalent, Dec 2, 2009 |
| Received | Sep 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092710
| 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 |
| Jan 17, 2017 | Pentax of America Inc Video Duodenoscope
These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includ Terminated |
FDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.