Atlas FDA

MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES

FDA 510(k) clearance K023984 · decided 2003-01-31

Clearance details

K-number
K023984
Device name
MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES
Applicant
The Olympus Optical Co.
Decision
Substantially Equivalent
Date received
2002-12-02
Decision date
2003-01-31
Days to decision
60 days
Clearance type
Traditional
Product code
EOQ
Device class
2
Regulation number
874.4680
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Melville, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150 recall (Z-0045-2026)Olympus Corporation of the Americas2025-10-16
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 recall (Z-0047-2026)Olympus Corporation of the Americas2025-10-16
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 recall (Z-0054-2026)Olympus Corporation of the Americas2025-10-16
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150 recall (Z-0055-2026)Olympus Corporation of the Americas2025-10-16
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 recall (Z-0058-2026)Olympus Corporation of the Americas2025-10-16
BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 recall (Z-0059-2026)Olympus Corporation of the Americas2025-10-16
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 recall (Z-0064-2026)Olympus Corporation of the Americas2025-10-16
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 recall (Z-0065-2026)Olympus Corporation of the Americas2025-10-16
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 recall (Z-0067-2026)Olympus Corporation of the Americas2025-10-16
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial recall (Z-0327-2024)Aizu Olympus Co., Ltd.2023-11-17
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS recall (Z-0189-2024)Olympus Corporation of the Americas2023-11-09
Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF- recall (Z-2490-2023)Olympus Corporation of the Americas2023-08-31
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60 recall (Z-2011-2023)Olympus Corporation of the Americas2023-07-17
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 recall (Z-2012-2023)Olympus Corporation of the Americas2023-07-17
Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150 recall (Z-2013-2023)Olympus Corporation of the Americas2023-07-17
Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160 recall (Z-2014-2023)Olympus Corporation of the Americas2023-07-17