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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K261015
Device Name Solo Scope Colonoscope System
Applicant
Gi View, Ltd.
5 Shoham St.
Ramat Gan,  IL 5251001
Applicant Contact Oded Nissan
Correspondent
A. Stein - Regulatory Affairs Consulting , Ltd.
18 Hataas St. (Suite 19)
Kfar Saba,  IL 4442518
Correspondent Contact Amit Goren
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Code
FET  
Date Received03/27/2026
Decision Date 08/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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