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

    HydroMARK Breast Biopsy Site Marker

    K Number: K212158 · Decision Apr 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    16
    Review Days
    283

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    Basic Information

    Device Name
    HydroMARK Breast Biopsy Site Marker
    K Number
    K212158
    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 12, 2021
    Decision Date
    April 21, 2022
    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
    K260365 Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char
    K253761 HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)
    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))
    K221961 HydroMARK Plus Breast Biopsy Site Marker
    K210752 HydroMARK Breast Biopsy Site Marker
    K203097 HydroMARK Breast Biopsy Site Markers
    K202012 Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
    K170803 HydroMARK Breast Biopsy Site Markers
    Search all 16 clearances from Devicor Medical Products, Inc. →