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

    CORTEK LAPAROSCOPES

    K Number: K000202 · Decision Mar 31, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    70

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    Basic Information

    Device Name
    CORTEK LAPAROSCOPES
    K Number
    K000202
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cortek Endoscopy, Inc.
    Date Received
    January 21, 2000
    Decision Date
    March 31, 2000
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Cortek Endoscopy, Inc.

    K Number Device Name
    K000199 CORTEK MINI LAPAROSCOPE
    K000198 CORTEK ARTHROSCOPE
    K000197 CORTEK CYSTOSCOPE
    K000200 CORTEK URETHEROSCOPE