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

    HYDROMARK BIOPSY SITE MARKER

    K Number: K060769 · Decision Jul 25, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    8
    Review Days
    125

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    HYDROMARK BIOPSY SITE MARKER
    K Number
    K060769
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biopsy Sciences, LLC
    Date Received
    March 22, 2006
    Decision Date
    July 25, 2006
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NEU), ordered by most recent decision date.

    HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MOLLI 2 System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SCOUT MD Surgical Guidance System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VizMark Preloaded Tissue Marker Device (VM-0001)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MammoSTAR Biopsy Site Identifier

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    UltraCor™ Twirl™ Breast Tissue Marker

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Biopsy Sciences, LLC

    K Number Device Name
    K130537 BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER
    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
    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