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

    EnCor MRI Introducer Set, EnCor Probe Introducer

    K Number: K161805 · Decision Jul 19, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    30
    Review Days
    18

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    Basic Information

    Device Name
    EnCor MRI Introducer Set, EnCor Probe Introducer
    K Number
    K161805
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Senorx, Inc.
    Date Received
    July 1, 2016
    Decision Date
    July 19, 2016
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNW Instrument, Biopsy

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    Other Clearances by Senorx, Inc.

    K Number Device Name
    K233220 EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)
    K210654 EnCor Breast Biopsy Probe with Rinse Tube
    K131654 STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER
    K093512 ENCOR BREAST BIOPSY SYSTEM
    K092323 CONTURA CAVITY MAINTENANCE CATHETER
    K082264 CONTURA LUMEN MARKER
    K081085 STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS
    K081170 PROSTATE TISSUE MARKER
    K081079 CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
    K080791 CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45
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