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

    ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY

    K Number: K861372 · Decision Jun 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    10
    Review Days
    69

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    Basic Information

    Device Name
    ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY
    K Number
    K861372
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Snowden-Pencer
    Date Received
    April 11, 1986
    Decision Date
    June 19, 1986
    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 Snowden-Pencer

    K Number Device Name
    K960400 DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)
    K930666 REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERY
    K930667 REUSABLE LAPAROSCOPIC INSTRUMENTS
    K924148 DIAMOND-SHARP(R) TROCARS
    K924149 ENDO I/A PROBE
    K920985 SNOWDEN-PENCER IRRIGATION PUMP
    K920986 SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700
    K913979 ENDO I/A Y SET
    K913835 SNOWDEN-PENCER INSUFFLATOR TUBING SET