510(k) K951574 ยท FDF Colonoscope And Accessories, Flexible/Rigid
EC-3800L, VIDEO COLONOSCOPE
| Applicant | Pentax Precision Instrument Corp., Miramar FL, US |
| Decision | Substantially Equivalent, Mar 21, 1996 |
| Received | Apr 4, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951574
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2016 | Pentax Medical Company Colonoscope
Product Usage:
Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissue Terminated |
FDF | None listed |
| Jul 23, 2016 | Pentax Medical Company Gastroscope
Product Usage:
Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissue Terminated |
FDF | None listed |
| 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.