510(k) K181240 ยท EOB Nasopharyngoscope (Flexible Or Rigid)
Rhino-Laryngo Fiberscope Olympus ENF-GP2
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Oct 4, 2018 |
| Received | May 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181240
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2020 | Olympus Corporation of the Americas ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen. Terminated |
EOB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.