510(k) K250862 ยท EOQ Bronchoscope (Flexible Or Rigid)
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)
| Applicant | Olympus Medical Systems Corp., Tokyo, JP |
| Decision | Substantially Equivalent, Jun 23, 2025 |
| Received | Mar 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250862
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2025 | Olympus Corporation of the Americas BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 Open, Classified |
EOQ | None listed |
| Oct 16, 2025 | Olympus Corporation of the Americas BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 Open, Classified |
EOQ | None listed |
| Oct 16, 2025 | Olympus Corporation of the Americas EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 Open, Classified |
EOQ | None listed |
| Oct 16, 2025 | Olympus Corporation of the Americas EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 Open, Classified |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.