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

    BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER

    K Number: K130537 · Decision Mar 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    8
    Review Days
    28

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    Basic Information

    Device Name
    BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER
    K Number
    K130537
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biopsy Sciences, LLC
    Date Received
    March 1, 2013
    Decision Date
    March 29, 2013
    Product Code
    NEU
    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
    NEU Marker, Radiographic, Implantable

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    Other Clearances by Biopsy Sciences, LLC

    K Number Device Name
    K121113 BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER
    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
    K041331 BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER
    K023694 BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER
    K021847 BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES