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510(k) Data Aggregation

    K Number
    K092554
    Device Name
    BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES
    Manufacturer
    SUNLIGHT MEDICAL, INC.
    Date Cleared
    2010-04-30

    (253 days)

    Product Code
    MQH, MOH
    Regulation Number
    884.6130
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNLIGHT MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blastomere Biopsy Pipettes: The intended use of the Blastomere Biopsy Pipettes is for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s). Polar Body Biopsy Pipettes: The intended use of the Polar Body Biopsy Pipettes is for removal of polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).
    Device Description
    The Blastomere Biopsy Pipettes are very fine glass pipettes used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of blastomere(s) from embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 18-42 um based customer's preferences and the stage of the embryos being biopsied. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10 - 45 degrees or straight. The Polar Body Biopsy Pipettes are very fine glass pipettes tools used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of polar bodies from oocytes and embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 13-15 um. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10-45 degrees or straight. Some of the tip may be pulled to form a sharp spike after polishing based customer's preferences. These devices are intended for one-time use and will be marked sterile. These devices are manufactured entirely from borosilicate glass. They are manufactured to specific sizes or the size may be modified to meet customer specifications, following procedures of the Sunlight Quality System. The final products are batch tested as part of a quality assurance program using Mouse Embryo Toxicity testing and endotoxin testing. The acceptance specifications of these tests are ≥80% of 2-cell mouse embryos to blastocysts and endotoxin ≤ 0.5 EU/device.
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    K Number
    K072600
    Device Name
    INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES
    Manufacturer
    SUNLIGHT MEDICAL, INC.
    Date Cleared
    2008-05-19

    (248 days)

    Product Code
    MQH
    Regulation Number
    884.6130
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNLIGHT MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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