510(k) K131902 ยท FDS Gastroscope And Accessories, Flexible/Rigid
PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
| Applicant | Pentax Medical Company, Montvale NJ, US |
| Decision | Substantially Equivalent, Apr 10, 2014 |
| Received | Jun 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131902
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 26, 2016 | Pentax of America Inc Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancilla Terminated |
FDS | None listed |
| Jun 28, 2016 | Pentax Medical Company Gastroscope
Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems Terminated |
FDS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.