
Medspira, LLC
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mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) is an FDA 510(k)-cleared medical device (K252605) manufactured by Medspira, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2025. Regulation: 8.