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

    PolypVac Microdebrider (3.3mm and 4.0mm)

    K Number: K161101 · Decision Jun 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    90
    Applicant Total
    8
    Review Days
    64

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    Basic Information

    Device Name
    PolypVac Microdebrider (3.3mm and 4.0mm)
    K Number
    K161101
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Laurimed, LLC
    Date Received
    April 19, 2016
    Decision Date
    June 22, 2016
    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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    Other Clearances by Laurimed, LLC

    K Number Device Name
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    K133133 LAURIMED POLYPVAC MICRODEBRIDER
    K091818 LAURIMED SPINAL INJECTION SYSTEM
    K090815 PERCUTANEOUS DISCECTOMY SYSTEM
    K083909 SPINAL INJECTION SYSTEM
    K082194 LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002
    K080140 LAURIMED SPINAL INJECTION SYSTEM