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

    RADIAL JAW 4 PULMONARY BIOPSY FORCEPS

    K Number: K121186 · Decision May 16, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    5
    Applicant Total
    432
    Review Days
    28

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    Basic Information

    Device Name
    RADIAL JAW 4 PULMONARY BIOPSY FORCEPS
    K Number
    K121186
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corp
    Date Received
    April 18, 2012
    Decision Date
    May 16, 2012
    Product Code
    BWH
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BWH Forceps, Biopsy, Bronchoscope (Non-Rigid)

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