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

    Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices

    K Number: K201244 · Decision Aug 7, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    2
    Review Days
    91

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    Basic Information

    Device Name
    Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
    K Number
    K201244
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Transmed7, LLC
    Date Received
    May 8, 2020
    Decision Date
    August 7, 2020
    Product Code
    KNW
    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
    KNW Instrument, Biopsy

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    Other Clearances by Transmed7, LLC

    K Number Device Name
    K173316 SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device