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

    ONCONTROL BONE MARROW BIOPSY SYSTEM

    K Number: K072045 · Decision Oct 22, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    19
    Review Days
    89

    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
    ONCONTROL BONE MARROW BIOPSY SYSTEM
    K Number
    K072045
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vidacare Corporation
    Date Received
    July 25, 2007
    Decision Date
    October 22, 2007
    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

    Similar 510(k) Clearances

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

    Promisemed VeriEcto Automatic Biopsy Needles

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    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

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EnCor EnCompass™ Breast Biopsy and Tissue Removal System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Resitu Slider 09 (RESL09)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Forcyte Autograft Harvest Kit

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Vidacare Corporation

    K Number Device Name
    K132583 EZ-IO INTRAOSSEOUS INFUSION SYSTEM
    K120661 THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE
    K113872 THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
    K101026 POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO
    K091140 EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO
    K081713 VERTEBRAL ACCESS SYSTEM BY VIDACARE
    K070759 POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM
    K063567 EZ-MIO STERNAL
    K063142 MANUAL PD-IO; POWERED PD-IO
    K062956 EZ-MIO, EZ-IO DISTAL TIBIA
    Search all 19 clearances from Vidacare Corporation →