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

    XPS 3000 SYSTEM

    K Number: K002224 · Decision Dec 4, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    90
    Applicant Total
    9
    Review Days
    133

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    Basic Information

    Device Name
    XPS 3000 SYSTEM
    K Number
    K002224
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Xomed
    Date Received
    July 24, 2000
    Decision Date
    December 4, 2000
    Product Code
    ERL
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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    K031510 NIM-SPINE
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    K000728 MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
    K990793 ACCUGUIDE MUSCLE INJECTION MONITOR
    K963727 HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER
    K963246 TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT