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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K261890
Device Name 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®
Applicant
Boehringer Laboratories, LLC
300 Thoms Dr.
Phoenixville,  PA  19460
Applicant Contact Evan Langdale
Correspondent
Boehringer Laboratories, LLC
300 Thoms Dr.
Phoenixville,  PA  19460
Correspondent Contact Evan Langdale
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/05/2026
Decision Date 08/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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