BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818

    K Number: K081323 · Decision Jul 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    11
    Review Days
    71

    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
    BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
    K Number
    K081323
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B-K Medical Aps
    Date Received
    May 12, 2008
    Decision Date
    July 22, 2008
    Product Code
    FCG
    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
    FCG Biopsy Needle

    Similar 510(k) Clearances

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

    Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)

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

    ClearTip FNA and FNB Types

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

    EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)

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

    Precision GI

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

    ClearTip

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

    EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)

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

    Other Clearances by B-K Medical Aps

    K Number Device Name
    K140428 ULTRASOUND SCANNER SYSTEM BK2300
    K132335 ULTRASOUND SCANNER FLEX FOCUS 1202
    K132346 ULTRASOUND SCANNER PRO FOCUS 2202
    K132677 ULTRASOUND SCANNER FLEX FOCUS 1202
    K132685 ULTRASOUND SCANNER PRO FOCUS 2202
    K123254 ULTRASOUND SCANNER FLEX FOCUS
    K100919 PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202
    K083667 NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337
    K081154 ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202
    K070077 ULTRASOUND SCANNER PROFOCUS, MODEL 2202
    Search all 11 clearances from B-K Medical Aps →