BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,

    K Number: K844876 · Decision Jun 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    8
    Review Days
    170

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    Basic Information

    Device Name
    PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,
    K Number
    K844876
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Pennine Medical , Ltd.
    Date Received
    December 17, 1984
    Decision Date
    June 5, 1985
    Product Code
    GBX
    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
    GBX Catheter, Irrigation

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    Other Clearances by Pennine Medical , Ltd.

    K Number Device Name
    K854443 O'NEIL URINARY CATHETER INTRODUCER
    K852859 PENNINE CONNECTING TUBING
    K852081 PENNINE OXYGEN LINK TUBING
    K844874 PENNINE LINK YANKAUERS
    K852079 PENNINE DERBY YANKAUER
    K852080 PENNINE SUCTION CATHETERS
    K844873 PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4