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

    Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics

    K Number: K171324 · Decision Jun 23, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    36
    Applicant Total
    8
    Review Days
    49

    Basic Information

    Device Name
    Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics
    K Number
    K171324
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instrument Service and Savings Inc
    Date Received
    May 5, 2017
    Decision Date
    June 23, 2017
    Product Code
    NUJ
    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
    NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

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