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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Gastrointestinal Motility (Electrical)
510(k) Number K252605
Device Name mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
Applicant
Medspira, LLC
2718 Summer St. NE
Minneapolis,  MN  55413
Applicant Contact Evan Johnston
Correspondent
Bluebird Consulting, LLC
301 Sugarbush Ln.
Elkhart Lake,  WI  53020
Correspondent Contact Melinda Swanson
Regulation Number876.1725
Classification Product Code
FFX  
Date Received08/18/2025
Decision Date 12/05/2025
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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