510(k) K033225 ยท EOQ Bronchoscope (Flexible Or Rigid)
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
| Applicant | Olympus Optical Co., Ltd., Melville NY, US |
| Decision | Substantially Equivalent, Oct 16, 2003 |
| Received | Oct 6, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033225
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Aug 31, 2023 | Olympus Corporation of the Americas Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60. Open, Classified |
EOQ | None listed |
| Mar 8, 2022 | Olympus Corporation of the Americas BF-MP160F: EVIS EXERA Bronchofibervideoscope Open, Classified |
EOQ | None listed |
| Aug 16, 2021 | Olympus Corporation of the Americas BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F Terminated |
EOQ | None listed |
| Aug 8, 2018 | Olympus Corporation of the Americas Bronchovideoscope BF-XP160F Terminated |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.