510(k) K201758 ยท EOQ Bronchoscope (Flexible Or Rigid)
EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Jan 21, 2021 |
| Received | Jun 29, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201758
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2024 | Shirakawa Olympus Co., Ltd. Model No. BF-P190, EVIS EXERA III Bronchovideoscope Open, Classified |
EOQ | None listed |
| Jan 9, 2024 | Shirakawa Olympus Co., Ltd. Model No. BF-XP190, EVIS EXERA III Bronchovideoscope Open, Classified |
EOQ | None listed |
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60 Open, Classified |
EOQ | None listed |
| Nov 9, 2023 | Olympus Corporation of the Americas EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190 Open, Classified |
EOQ | None listed |
| Aug 31, 2023 | Olympus Corporation of the Americas Olympus Bronchovideoscope, Models BF-P190 & BF-XP190. Open, Classified |
EOQ | None listed |
| Jul 20, 2022 | Aizu Olympus Co., Ltd. EVIS EXERA III Bronchovideoscope Terminated |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.