BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Single Use Arthroscopic Electrode (with Pencil)

    K Number: K170703 · Decision May 31, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    4
    Review Days
    449

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    Basic Information

    Device Name
    Single Use Arthroscopic Electrode (with Pencil)
    K Number
    K170703
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Modern Medical Equipment Manufacturing Limited
    Date Received
    March 8, 2017
    Decision Date
    May 31, 2018
    Product Code
    HRX
    Advisory Committee
    Orthopedic
    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
    HRX Arthroscope

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    Other Clearances by Modern Medical Equipment Manufacturing Limited

    K Number Device Name
    K163442 Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)
    K152059 Disposable General Electrode
    K134006 DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE