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

    CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX

    K Number: K080946 · Decision May 20, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    2
    Review Days
    47

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    Basic Information

    Device Name
    CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
    K Number
    K080946
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Conmed Endoscopic Technologies, Inc.
    Date Received
    April 3, 2008
    Decision Date
    May 20, 2008
    Product Code
    KNS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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    Other Clearances by Conmed Endoscopic Technologies, Inc.

    K Number Device Name
    K091355 DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998