510(k) K963056 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
ED-3410, VIDEO DUODENOSCOPE
| Applicant | Pentax Precision Instrument Corp., Miramar FL, US |
| Decision | Substantially Equivalent, Oct 10, 1996 |
| Received | Aug 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963056
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Jul 23, 2016 | Pentax Medical Company Duodenoscope
Product Usage:
Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; an Terminated |
FDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.