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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K261102
Device Name UNIDRIVE Select System
Applicant
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Straße 34
Baden-Wurttemberg
Tuttlingen,  DE 78532
Applicant Contact McElroy Alita
Correspondent
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Straße 34
Baden-Wurttemberg
Tuttlingen,  DE 78532
Correspondent Contact McElroy Alita
Regulation Number884.1690
Classification Product Code
HIH  
Date Received04/03/2026
Decision Date 09/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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