K250862

EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)

510(k) number: K250862
Device name: EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)
Applicant: Olympus Medical Systems Corp. JP
Product code: EOQ — Bronchoscope (Flexible Or Rigid)
Decision date: 2025-06-23
Date received: 2025-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Ear, Nose, Throat

PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K250862.pdf

Official FDA record: K250862

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