ClearanceBrief
510(k) K033225 ยท EOQ Bronchoscope (Flexible Or Rigid)

EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT

ApplicantOlympus Optical Co., Ltd., Melville NY, US
DecisionSubstantially Equivalent, Oct 16, 2003
ReceivedOct 6, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K033225

DateFirm and productCodeLinked 510(k)
Nov 17, 2023Aizu 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
EOQNone listed
Aug 31, 2023Olympus Corporation of the Americas
Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
Open, Classified
EOQNone listed
Mar 8, 2022Olympus Corporation of the Americas
BF-MP160F: EVIS EXERA Bronchofibervideoscope
Open, Classified
EOQNone listed
Aug 16, 2021Olympus Corporation of the Americas
BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
Terminated
EOQNone listed
Aug 8, 2018Olympus Corporation of the Americas
Bronchovideoscope BF-XP160F
Terminated
EOQNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.