510(k) K221660 ยท EOB Nasopharyngoscope (Flexible Or Rigid)
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Dec 28, 2022 |
| Received | Jun 8, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221660
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2024 | Shirakawa Olympus Co., Ltd. Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE Open, Classified |
EOB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.