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

    HydroMARK Plus Breast Biopsy Site Marker

    K Number: K221961 · Decision Jul 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    104
    Applicant Total
    8
    Review Days
    373

    Basic Information

    Device Name
    HydroMARK Plus Breast Biopsy Site Marker
    K Number
    K221961
    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
    Devicor Medical Products, Inc.
    Date Received
    July 5, 2022
    Decision Date
    July 13, 2023
    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 Devicor Medical Products, Inc.

    K Number Device Name
    K243095 Mammotome AutoCore™ Single Insertion Core Biopsy System
    K240527 HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
    K232615 LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))
    K212158 HydroMARK Breast Biopsy Site Marker
    K210752 HydroMARK Breast Biopsy Site Marker
    K202012 Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
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