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

    EnCor EnCompass™ Breast Biopsy and Tissue Removal System

    K Number: K252681 · Decision Dec 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    34
    Review Days
    109

    Basic Information

    Device Name
    EnCor EnCompass™ Breast Biopsy and Tissue Removal System
    K Number
    K252681
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bard Peripheral Vascular, Inc.
    Date Received
    August 25, 2025
    Decision Date
    December 12, 2025
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    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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