LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974224
    Device Name
    ENDOLYMPHATIC SAC TO MASTOID T-SHUNT
    Manufacturer
    EXMOOR PLASTICS LTD.
    Date Cleared
    1998-01-27

    (78 days)

    Product Code
    ESZ
    Regulation Number
    874.3820
    Why did this record match?
    Search-Everything :

    Matched: '874.3820'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endolymphatic Sac fluid increases during Meniere's disease attacks. This simple 'T' type endolymphatic sac shunt is designed to act as a continuous drain, allowing endolymphatic sac fluid to be shunted into the Mastoid. The shunt is placed in the sac along with decompression of the sac and the adjacent dura.
    Device Description
    This device is a small, T-shaped piece of silicone rubber sheet, approximately 8.5mm x 1mm x 0.125mm. The T-bar is 5mm wide.
    Ask a Question

    Page 1 of 1