BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)

    K Number: K252605 · Decision Dec 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    68
    Applicant Total
    3
    Review Days
    109

    Basic Information

    Device Name
    mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
    K Number
    K252605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1725
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medspira, LLC
    Date Received
    August 18, 2025
    Decision Date
    December 5, 2025
    Product Code
    FFX
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FFX System, Gastrointestinal Motility (Electrical)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FFX), ordered by most recent decision date.

    Solar Compact (G4-1)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EndoflipTM 300 System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EndoflipTM 300

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Transit-Pellets

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    IntraMarX 3D Radiopaque Marker

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    IntraMarX Radiopaque Markers

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Medspira, LLC

    K Number Device Name
    K143031 mcompass Biofeedback Anorectal Manometry System
    K120088 MCOMPASS ANORECTAL MANOMETRY SYSTEM