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

    NTECH CYSTOSCOPES

    K Number: K980592 · Decision Apr 28, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    3
    Review Days
    70

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    Basic Information

    Device Name
    NTECH CYSTOSCOPES
    K Number
    K980592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    N-Tech Endoscopy, Inc.
    Date Received
    February 17, 1998
    Decision Date
    April 28, 1998
    Product Code
    FAJ
    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
    FAJ Cystoscope And Accessories, Flexible/Rigid

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    Other Clearances by N-Tech Endoscopy, Inc.

    K Number Device Name
    K980623 N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE
    K980599 NTECH ARTHROSCOPE