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

    PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1

    K Number: K992361 · Decision Aug 20, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    74
    Applicant Total
    6
    Review Days
    36

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    Basic Information

    Device Name
    PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1
    K Number
    K992361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pall Medical
    Date Received
    July 15, 1999
    Decision Date
    August 20, 1999
    Product Code
    FYD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FYD Apparatus, Exhaust, Surgical

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    Other Clearances by Pall Medical

    K Number Device Name
    K033991 MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET
    K030469 LAPAROSHIELD CONDITIONED INSUFFLATION SET
    K013093 PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
    K983735 PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE
    K983731 PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE