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

    REPROCESSED TROCARS AND CANNULAS

    K Number: K012644 · Decision Jul 29, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    8
    Review Days
    350

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    Basic Information

    Device Name
    REPROCESSED TROCARS AND CANNULAS
    K Number
    K012644
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instruments Service and Savings, Inc.
    Date Received
    August 13, 2001
    Decision Date
    July 29, 2002
    Product Code
    NLM
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NLM Laparoscope, General & Plastic Surgery, Reprocessed

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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
    K012669 REPROCESSED ELECTROSURGICAL ELECTRODES
    K012667 REPROCESSED ARTHROSCOPIC SHAPERS
    K012658 REPROCESSED COMPRESSION LIMB SLEEVES