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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Esophageal Motility, Anorectal Motility, And Tube
510(k) Number K242666
Device Name Fecobionics Anorectal System
Applicant
GI Bionics, LLC
11107 Roselle Street
Suite 213
San Diego,  CA  92121
Applicant Contact Ricardo Villanueva
Correspondent
Cygnus Regulatory
6224 N 38th Street
Paradise Valley,  AZ  85253
Correspondent Contact Natalie Eagleburger
Regulation Number876.1725
Classification Product Code
KLA  
Date Received09/05/2024
Decision Date 02/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT03317938
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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