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

    BRIMFIELD PRECISION GRASPER/DISSECTOR

    K Number: K946263 · Decision Jan 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    8
    Review Days
    34

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    Basic Information

    Device Name
    BRIMFIELD PRECISION GRASPER/DISSECTOR
    K Number
    K946263
    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
    December 23, 1994
    Decision Date
    January 26, 1995
    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
    K953410 BRIMFIELD PRECISION ARTICULATING FAN RETRACTOR
    K952785 BRIMFIELD PRECISION DETACHABLE SCISSOR
    K942499 INSULATED SURGICAL ELECTRODE
    K941276 BRIMFIELD PRECISION SECOND GENERATION GRASPER/DISSECTOR
    K941316 BRIMFIELD PRECISION FAN RETRACTOR
    K933388 BRIMFIELD PRECISION SCISSOR
    K933387 BRIMFIELD PRECISION GRASPER/DISSECTOR