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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K254299
Device Name CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)
Applicant
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Straße 34
Tuttlingen,  DE 78532
Applicant Contact Jennifer Downing
Correspondent
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Straße 34
Tuttlingen,  DE 78532
Correspondent Contact Jennifer Downing
Regulation Number874.4760
Classification Product Code
EOB  
Date Received12/31/2025
Decision Date 09/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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