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

    RUTNER BIOPSY DEVICE

    K Number: K950810 · Decision Mar 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    104
    Review Days
    12

    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
    RUTNER BIOPSY DEVICE
    K Number
    K950810
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Urological, Inc.
    Date Received
    February 22, 1995
    Decision Date
    March 6, 1995
    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 Cook Urological, Inc.

    K Number Device Name
    K102141 COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
    K091767 3 WAY SILICONE FOLEY BALLOON CATHETER
    K082939 COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
    K082066 TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
    K082536 COOK WIRE GUIDES
    K082319 INJEKT FILIFORM INJECTION NEEDLE
    K080525 COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
    K073496 OPTILITE HOLMIUM LASER FIBERS
    K072521 COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
    K061371 SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
    Search all 104 clearances from Cook Urological, Inc. →