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

    REPROCESSED COMPRESSION LIMB SLEEVES

    K Number: K012658 · Decision May 14, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    8
    Review Days
    274

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    Basic Information

    Device Name
    REPROCESSED COMPRESSION LIMB SLEEVES
    K Number
    K012658
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instruments Service and Savings, Inc.
    Date Received
    August 13, 2001
    Decision Date
    May 14, 2002
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Surgical Instruments Service and Savings, Inc.

    K Number Device Name
    K124033 MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS
    K031869 SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
    K030179 MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
    K024011 SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES
    K012644 REPROCESSED TROCARS AND CANNULAS
    K012669 REPROCESSED ELECTROSURGICAL ELECTRODES
    K012667 REPROCESSED ARTHROSCOPIC SHAPERS