510(k) K953286 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
FCP-9P, FIBER CHOLEDOCHOSCOPE
| Applicant | Pentax Precision Instrument Corp., Miramar FL, US |
| Decision | Substantially Equivalent, Nov 3, 1995 |
| Received | Jul 13, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2016 | Pentax Medical Company Choledochoscope
Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bil Terminated |
FBN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.