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

    MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS

    K Number: K124033 · Decision Jan 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    26
    Applicant Total
    8
    Review Days
    375

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    Basic Information

    Device Name
    MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS
    K Number
    K124033
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instruments Service and Savings, Inc.
    Date Received
    December 28, 2012
    Decision Date
    January 7, 2014
    Product Code
    NLQ
    Advisory Committee
    Unknown
    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
    NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments

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    Other Clearances by Surgical Instruments Service and Savings, Inc.

    K Number Device Name
    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
    K012658 REPROCESSED COMPRESSION LIMB SLEEVES