510(k) K120446 ยท FDS Gastroscope And Accessories, Flexible/Rigid
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
| Applicant | Fujinon, Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Aug 13, 2012 |
| Received | Feb 14, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120446
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2013 | Fujinon Inc Fujinon/Fujifilm Ultrasonic Endoscope
Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment Terminated |
FDS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.