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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteroscope And Accessories
510(k) Number K260314
Device Name Ancora-SB
Applicant
Aspero Medical, Inc.
10835 Dover St.
Suite 800
Westminster,  CO  80021
Applicant Contact Mark Rentschler
Correspondent
Nancy Sauer Regulatory Consulting, LLC
401 Spruce St.
Louisville,  CO  80027
Correspondent Contact Nancy Sauer
Regulation Number876.1500
Classification Product Code
FDA  
Subsequent Product Code
FED  
Date Received01/30/2026
Decision Date 05/01/2026
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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