BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Tumark for Eviva, Tumark for Brevera

    K Number: K182082 · Decision Oct 31, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    7
    Review Days
    90

    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
    Tumark for Eviva, Tumark for Brevera
    K Number
    K182082
    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
    Somatex Medical Technologies GmbH
    Date Received
    August 2, 2018
    Decision Date
    October 31, 2018
    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 Somatex Medical Technologies GmbH

    K Number Device Name
    K201863 Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
    K180443 Tumark Vision
    K111692 TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
    K102771 BIOPSY HANDY, MRI BIOPSY HANDY
    K093064 TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560
    K073095 TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560