Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K251731

KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)

510(k) number
K251731
Device name
KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)
Applicant
Karl Storz SE & CO. KG DE
Product code
EOQ — Bronchoscope (Flexible Or Rigid)
Decision date
2025-12-05
Date received
2025-06-06
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain

Also available from FDA: K251731.pdf

Official FDA record: K251731
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.