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

    BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER

    K Number: K041331 · Decision Jun 15, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    8
    Review Days
    27

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    Basic Information

    Device Name
    BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER
    K Number
    K041331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biopsy Sciences, LLC
    Date Received
    May 19, 2004
    Decision Date
    June 15, 2004
    Product Code
    GDW
    Advisory Committee
    General, Plastic Surgery
    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
    GDW Staple, Implantable

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    K090501 BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1
    K083006 BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER
    K060769 HYDROMARK BIOPSY SITE MARKER
    K023694 BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER
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