510(k) K951578 ยท FDF Colonoscope And Accessories, Flexible/Rigid
FC-38LX, FIBER COLONOSCOPE
| Applicant | Pentax Precision Instrument Corp., Miramar FL, US |
| Decision | Substantially Equivalent, Jun 27, 1995 |
| Received | Apr 4, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951578
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2016 | Pentax Medical Company Colonoscope
Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems Terminated |
FDF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.