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

    Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord

    K Number: K243568 · Decision Jan 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    125
    Review Days
    60

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    Basic Information

    Device Name
    Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
    K Number
    K243568
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wilson-Cook Medical, Inc.
    Date Received
    November 18, 2024
    Decision Date
    January 17, 2025
    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 Wilson-Cook Medical, Inc.

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