510(k) K850020 ยท FDS Gastroscope And Accessories, Flexible/Rigid
PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
| Applicant | Pentax Precision Instrument Corp., Orangeburg NY, US |
| Decision | Substantially Equivalent, Jul 9, 1985 |
| Received | Jan 4, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850020
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2016 | Pentax Medical Company Gastroscope
Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems Terminated |
FDS | None listed |
| Aug 21, 2014 | Pentax Medical Company PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve Terminated |
KOG | None listed |
| Oct 28, 2013 | Pentax Medical Company PENTAX Endoscopic Accessories. OF-B194. Made in Japan.
PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used Terminated |
FCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.