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

    WILTEK PAPILLOTOME

    K Number: K894861 · Decision Dec 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    21
    Review Days
    143

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    Basic Information

    Device Name
    WILTEK PAPILLOTOME
    K Number
    K894861
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Wiltek Medical, Inc.
    Date Received
    July 31, 1989
    Decision Date
    December 21, 1989
    Product Code
    KNS
    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
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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    Other Clearances by Wiltek Medical, Inc.

    K Number Device Name
    K990231 WILTEK HOT BIOPSY FORCEPS
    K922989 WILTEK IRRIGAITON/ASPIRATION TUBE SET
    K930419 WILTEK BIOPSY FORCEPS
    K914882 WILTEK BALLOON CHOLANGIOGRAPHY CATHETER
    K914881 WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
    K914132 WILTEK ELECTROCAUTERY ACTIVE CORD
    K914131 WILTEK ELECTROCAUTERY ADAPTOR
    K912122 CHOLANGIOGRAPHY CATHETER
    K912288 WILTEK STANDARD CHOLANGIOGRAPHY CATHETER
    K910334 ELECTROCAUTERY PROBE
    Search all 21 clearances from Wiltek Medical, Inc. →