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

    BRIMFIELD PRECISION FAN RETRACTOR

    K Number: K941316 · Decision Apr 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    573
    Same Product Code
    1391
    Applicant Total
    8
    Review Days
    35

    Basic Information

    Device Name
    BRIMFIELD PRECISION FAN RETRACTOR
    K Number
    K941316
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SPRINGFIELD SURGICAL INSTRUMENTS
    Date Received
    March 18, 1994
    Decision Date
    April 22, 1994
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by SPRINGFIELD SURGICAL INSTRUMENTS

    K Number Device Name
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    K952785 BRIMFIELD PRECISION DETACHABLE SCISSOR
    K946263 BRIMFIELD PRECISION GRASPER/DISSECTOR
    K942499 INSULATED SURGICAL ELECTRODE
    K941276 BRIMFIELD PRECISION SECOND GENERATION GRASPER/DISSECTOR
    K933388 BRIMFIELD PRECISION SCISSOR
    K933387 BRIMFIELD PRECISION GRASPER/DISSECTOR