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

    DIAMOND-SHARP(R) TROCARS

    K Number: K924148 · Decision Feb 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    10
    Review Days
    559

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    Basic Information

    Device Name
    DIAMOND-SHARP(R) TROCARS
    K Number
    K924148
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Snowden-Pencer
    Date Received
    August 18, 1992
    Decision Date
    February 28, 1994
    Product Code
    HFI
    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
    HFI Coagulator, Culdoscopic (And Accessories)

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    Other Clearances by Snowden-Pencer

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    K930667 REUSABLE LAPAROSCOPIC INSTRUMENTS
    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
    K861372 ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY