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

    SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS

    K Number: K052695 · Decision May 10, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    36
    Applicant Total
    4
    Review Days
    224

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    Basic Information

    Device Name
    SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS
    K Number
    K052695
    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
    Suretek Medical
    Date Received
    September 28, 2005
    Decision Date
    May 10, 2006
    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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    Other Clearances by Suretek Medical

    K Number Device Name
    K052691 SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES
    K052690 SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS
    K052692 SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES