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

    Quiver Aspiration Pump

    K Number: K232831 · Decision Feb 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    2
    Review Days
    162

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    Basic Information

    Device Name
    Quiver Aspiration Pump
    K Number
    K232831
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anoxia Medical, Inc.
    Date Received
    September 13, 2023
    Decision Date
    February 22, 2024
    Product Code
    BTA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Anoxia Medical, Inc.

    K Number Device Name
    K231179 Slinky Catheter