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

    NEZHAT-DORESEY PENCIL-GRIP HANDLES

    K Number: K951732 · Decision May 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    18
    Review Days
    40

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    Basic Information

    Device Name
    NEZHAT-DORESEY PENCIL-GRIP HANDLES
    K Number
    K951732
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Hydro-Surgical Instruments, Inc.
    Date Received
    April 14, 1995
    Decision Date
    May 24, 1995
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by American Hydro-Surgical Instruments, Inc.

    K Number Device Name
    K953574 NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER
    K953481 NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER
    K952070 NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS
    K946380 NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)
    K951300 NEZHAT-DORSEY THERMAL RETENTION SYSTEM
    K950499 NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS
    K951119 NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM
    K952421 NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS
    K951733 NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COAGULATION HAND CONTROLS
    K951731 NEZHAT-DORESY ELECTROSURGICAL HAND CONTROL ATTACHMENTS
    Search all 18 clearances from American Hydro-Surgical Instruments, Inc. →