BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Peleton Universal Single Use Power System and Attachments

    K Number: K240071 · Decision Apr 4, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    85

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    Basic Information

    Device Name
    Peleton Universal Single Use Power System and Attachments
    K Number
    K240071
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Peleton Surgical
    Date Received
    January 10, 2024
    Decision Date
    April 4, 2024
    Product Code
    SAM
    Advisory Committee
    General, Plastic Surgery
    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
    SAM Battery-Powered Instruments Charged Through Sterile Barriers