510(k) K951572 ยท FAM Sigmoidoscope And Accessories, Flexible/Rigid
FS-38X, FIBER SIGMOIDOSCOPE
| 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 K951572
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2016 | Pentax Medical Company Signmoidoscope
Product Usage:
Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissue Terminated |
FAM | None listed |
| Jun 28, 2016 | Pentax Medical Company Signmoidoscope
Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystem Terminated |
FAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.