510(k) K962897 ยท FDS Gastroscope And Accessories, Flexible/Rigid
EG-3400, VIDEO GASTROSCOPE
| Applicant | Pentax Precision Instrument Corp., Miramar FL, US |
| Decision | Substantially Equivalent, Oct 4, 1996 |
| Received | Jul 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962897
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.