510(k) K961974 ยท ITX Transducer, Ultrasonic, Diagnostic
FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE
| Applicant | Pentax Precision Instrument Corp., Miramar FL, US |
| Decision | Substantially Equivalent, Feb 10, 1997 |
| Received | May 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961974
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2016 | Pentax Medical Company Ultrasound Gastroscope
Product Usage:
Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricte Terminated |
ODG | None listed |
| Jun 28, 2016 | Pentax Medical Company Ultrasound Gastroscope
Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tis Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.