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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K251731
Device Name KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)
Applicant
Karl Storz SE & CO. KG
2151 E. Grand Ave.
Dr.-Karl-Storz-Straße 34 Baden-Wurttemberg
Tuttlingen,  DE 78532
Applicant Contact Trujillo Mario
Correspondent
Karl Storz SE & CO. KG
2151 E. Grand Ave.
Dr.-Karl-Storz-Straße 34 Baden-Wurttemberg
Tuttlingen,  DE 78532
Correspondent Contact Mario Trujillo
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received06/06/2025
Decision Date 12/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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