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

    SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES

    K Number: K031869 · Decision Dec 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    8
    Review Days
    190

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    Basic Information

    Device Name
    SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
    K Number
    K031869
    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 Instruments Service and Savings, Inc.
    Date Received
    June 17, 2003
    Decision Date
    December 24, 2003
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Surgical Instruments Service and Savings, Inc.

    K Number Device Name
    K124033 MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS
    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
    K012658 REPROCESSED COMPRESSION LIMB SLEEVES