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510(k) Data Aggregation

    K Number
    K200680
    Device Name
    Synvitro Hyadase
    Manufacturer
    Origio a/s, a CooperSurgical Company
    Date Cleared
    2020-07-17

    (123 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    Origio a/s, a CooperSurgical Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SynVitro® Hyadase is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
    Device Description
    SynVitro® Hyadase is a modified version of the prior cleared SynVitro® Hyadase device and is used for removal of cumulus and corona radiata cells surrounding the oocytes (denudation) prior to intracytoplasmic sperm injection (ICSI). SynVitro® Hyadase is a clear non-viscous hyaluronidase enzyme solution contained in a 2 ml transparent plastic bottles (containing 1 ml solution) with caps and provided in cardboard boxes containing five bottles. This product has a one-year shelf-life when stored as recommended and can be used for up to seven days after opening.
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