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

    Renova RP Centesis Pump

    K Number: K221042 · Decision Apr 19, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    2
    Review Days
    376

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    Basic Information

    Device Name
    Renova RP Centesis Pump
    K Number
    K221042
    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
    Gi Supply, Inc.
    Date Received
    April 8, 2022
    Decision Date
    April 19, 2023
    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 Gi Supply, Inc.

    K Number Device Name
    K202376 EverLift Submucosal Lifting Agent