ClearanceBrief
510(k) K121959 ยท EOQ Bronchoscope (Flexible Or Rigid)

EVIS EXERA III VIDEO SYSTEM

ApplicantOlympus Medical Systems Corp., Center Valley PA, US
DecisionSubstantially Equivalent, Jan 10, 2013
ReceivedJul 5, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K121959

DateFirm and productCodeLinked 510(k)
Oct 16, 2025Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
Open, Classified		 EOQNone listed
Oct 16, 2025Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
Open, Classified		 EOQNone listed
Oct 16, 2025Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
Open, Classified		 EOQNone listed
Oct 16, 2025Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF-Q170
Open, Classified		 EOQNone listed
Oct 16, 2025Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
Open, Classified		 EOQNone listed
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
Nov 9, 2023Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
Open, Classified		 NWBNone listed
Aug 31, 2023Olympus Corporation of the Americas
Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.
Open, Classified		 EOQNone listed
Jul 17, 2023Olympus Corporation of the Americas
Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
Open, Classified		 EOQNone listed
Jul 17, 2023Olympus Corporation of the Americas
Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
Open, Classified		 EOQNone listed

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