K251823

UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)

510(k) number
K251823
Device name
UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)
Applicant
Zhejiang UE Medical Corp. CN
Product code
EOQ — Bronchoscope (Flexible Or Rigid)
Decision date
2025-08-11
Date received
2025-06-13
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K251823.pdf

Official FDA record: K251823
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.