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

    SODEM POWER SYSTEM

    K Number: K935567 · Decision Jan 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    387
    Registration Numbers
    387
    Same Product Code
    75
    Applicant Total
    8
    Review Days
    64

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    Basic Information

    Device Name
    SODEM POWER SYSTEM
    K Number
    K935567
    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
    Sodemsystems
    Date Received
    November 18, 1993
    Decision Date
    January 21, 1994
    Product Code
    HWE
    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
    HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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    Other Clearances by Sodemsystems

    K Number Device Name
    K023070 SODEM HIGH SPEED SYSTEM (PNEUMATIC)
    K023066 DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
    K012453 SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)
    K012457 SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
    K012456 SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
    K993851 SODEM PERFORATOR DRIVE
    K994175 MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE