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

    Radial Jaw 4 Pulmonary Biopsy Forceps

    K Number: K252921 · Decision Sep 26, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    5
    Applicant Total
    231
    Review Days
    14

    Basic Information

    Device Name
    Radial Jaw 4 Pulmonary Biopsy Forceps
    K Number
    K252921
    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 Corporation
    Date Received
    September 12, 2025
    Decision Date
    September 26, 2025
    Product Code
    BWH
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    AN
    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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