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

    ENDO I/A Y SET

    K Number: K913979 · Decision Nov 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    176
    Applicant Total
    10
    Review Days
    82

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    Basic Information

    Device Name
    ENDO I/A Y SET
    K Number
    K913979
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1730
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Snowden-Pencer
    Date Received
    September 6, 1991
    Decision Date
    November 27, 1991
    Product Code
    HIF
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HIF Insufflator, Laparoscopic

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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
    K913835 SNOWDEN-PENCER INSUFFLATOR TUBING SET
    K861372 ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY