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

    GPS Advanced; GPS Advanced Cannula

    K Number: K251648 · Decision Jun 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    553
    Registration Numbers
    553
    Same Product Code
    738
    Applicant Total
    2
    Review Days
    26

    Basic Information

    Device Name
    GPS Advanced; GPS Advanced Cannula
    K Number
    K251648
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prosidyan, Inc.
    Date Received
    May 29, 2025
    Decision Date
    June 24, 2025
    Product Code
    FMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMF Syringe, Piston

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    Other Clearances by Prosidyan, Inc.

    K Number Device Name
    K241426 GPS Advanced; 5 cc GPS Advanced Cannula