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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Confocal Optical Imaging
510(k) Number K253972
Device Name IMAGE1 (TC400US); X-to-4U Adapter (TC040)
Applicant
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Straße 34
Tuttlingen,  DE 78532
Applicant Contact Winkie Wong
Correspondent
Karl Storz SE & CO. KG
Dr.-Karl-Storz-Straße 34
Tuttlingen,  DE 78532
Correspondent Contact Winkie Wong
Regulation Number876.1500
Classification Product Code
OWN  
Date Received12/11/2025
Decision Date 02/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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