510(k) K914008 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P
| Applicant | Pentax Precision Instrument Corp., Orangeburg NY, US |
| Decision | Substantially Equivalent, Jan 10, 1992 |
| Received | Sep 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914008
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2016 | Pentax Medical Company Cystoscope
Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Terminated |
FAJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.