510(k) K951191 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE
| Applicant | Pentax Precision Instrument Corp., Miramar FL, US |
| Decision | Substantially Equivalent, May 30, 1995 |
| Received | Mar 16, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951191
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2016 | Pentax Medical Company Choledocho-Nephroscope
Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Terminated |
FBN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.