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

    Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector

    K Number: K173627 · Decision Jul 12, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    23
    Review Days
    230

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    Basic Information

    Device Name
    Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
    K Number
    K173627
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instrument Service and Savings, Inc.
    Date Received
    November 24, 2017
    Decision Date
    July 12, 2018
    Product Code
    NLQ
    Advisory Committee
    Unknown
    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
    NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments

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