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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K253702
Device Name Intuitive Endoluminal Gastrointestinal System (IG1000)
Applicant
Intuitive Surgical, Inc.
1266 Kifer Rd.
Sunnyvale,  CA  94086
Applicant Contact Einav Yemini
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Rd.
Sunnyvale,  CA  94086
Correspondent Contact Einav Yemini
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
FET  
Date Received11/24/2025
Decision Date 08/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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