510(k) K961564 ยท FDS Gastroscope And Accessories, Flexible/Rigid
EG-2940, VIDEO GASTROSCOPE
| Applicant | Pentax Precision Instrument Corp., Miramar FL, US |
| Decision | Substantially Equivalent, Jul 9, 1996 |
| Received | Apr 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961564
| 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 |
| Jan 20, 2012 | Pentax Medical Company EE- Series Video Esophagoscopes, EE-1580K.
Intended to provide optical visualization of (via a video monitor) and therapeutic access to, the Upper Gastrointestinal Track. Terminated |
EOX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.