510(k) K061313 ยท EOQ Bronchoscope (Flexible Or Rigid)
EVIS EXERA 180 SYSTEM
| Applicant | Olympus Medical Systems Corporation, Center Valley PA, US |
| Decision | Substantially Equivalent, Aug 31, 2006 |
| Received | May 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061313
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2026 | Olympus Corporation of the Americas Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box.
The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflu Open, Classified |
EOQ | None listed |
| Mar 3, 2026 | Olympus Corporation of the Americas Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box.
The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent lea Open, Classified |
EOQ | None listed |
| Oct 16, 2025 | Olympus Corporation of the Americas EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 Open, Classified |
EOQ | None listed |
| Oct 16, 2025 | Olympus Corporation of the Americas EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 Open, Classified |
EOQ | None listed |
| Oct 16, 2025 | Olympus Corporation of the Americas EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180 Open, Classified |
EOQ | None listed |
| Oct 16, 2025 | Olympus Corporation of the Americas EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 Open, Classified |
EOQ | None listed |
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including
nasopharyngeal and trachea).
Model Numbers: ENF-T3, ENF-VT2, ENF-VT3. Open, Classified |
EOQ | None listed |
| Nov 9, 2023 | Olympus Corporation of the Americas EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180 Open, Classified |
NWB | None listed |
| Aug 31, 2023 | Olympus Corporation of the Americas Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180. Open, Classified |
EOQ | None listed |
| Jul 17, 2023 | Olympus Corporation of the Americas Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180 Open, Classified |
EOQ | None listed |
| Mar 8, 2022 | Olympus Corporation of the Americas BF-1TQ180: EVIS EXERA II Bronchovideoscope Open, Classified |
EOQ | None listed |
| Aug 16, 2021 | Olympus Corporation of the Americas BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180 Terminated |
EOQ | None listed |
| Aug 16, 2021 | Olympus Corporation of the Americas BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180 Terminated |
EOQ | None listed |
| Aug 31, 2020 | Olympus Corporation of the Americas Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, l Terminated |
EOQ | None listed |
| Aug 8, 2018 | Olympus Corporation of the Americas Bronchovideoscope BF-1T180 Terminated |
EOQ | None listed |
| Aug 8, 2018 | Olympus Corporation of the Americas Bronchovideoscope F-1TQ180 Terminated |
EOQ | None listed |
| Aug 8, 2018 | Olympus Corporation of the Americas Bronchovideoscope BF-P180 Terminated |
EOQ | None listed |
| Aug 8, 2018 | Olympus Corporation of the Americas Bronchovideoscope BF-Q180 Terminated |
EOQ | None listed |
| Aug 8, 2018 | Olympus Corporation of the Americas Rhino Laryngo scope ENF-VT2 Terminated |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.