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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 K254252
Device Name UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)
Applicant
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Straße 34
Baden-Wurttemberg
Tuttlingen,  DE 78532
Applicant Contact Alita McElroy
Correspondent
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Straße 34
Baden-Wurttemberg
Tuttlingen,  DE 78532
Correspondent Contact Alita McElroy
Regulation Number884.1690
Classification Product Code
HIH  
Date Received12/29/2025
Decision Date 09/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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