K252341

EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)

510(k) number
K252341
Device name
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)
Applicant
Olympus Medical Systems Corp. JP
Product code
EOQ — Bronchoscope (Flexible Or Rigid)
Decision date
2026-04-23
Date received
2025-07-28
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain

Also available from FDA: K252341.pdf

Official FDA record: K252341
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.