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510(k) Data Aggregation

    K Number
    K102480
    Device Name
    INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA
    Manufacturer
    JIEYING LABORATORY INC.
    Date Cleared
    2011-04-19

    (232 days)

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

    JIEYING LABORATORY INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The manufactured microtools are to be used for Assisted Reproductive Technology (ART) and Reproductive Medicine (RM), and the specific pipette indication is as follows: Injection Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for intracytoplasmic sperm injection (ICSI) Holding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for holding oocyte or embryo during ICSI or biopsy Biopsy Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories 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 Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of polar bodies from occytes, which may be done in order to perform pre implantation genetic diagnosis on the genetic material in the biopsied cell(s) Assisted Hatching Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to create a defect in the zona pellucida chemically using Tyrode's acid solution in order to perform assisted hatching of embryos Denuding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to denuding cumulus cells from oocytes by delivering enzymes to aid separation Partial Zona Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to cut zona pellucida to create a defect in the zona pellucida mechanically in order to perform assisted hatching of embryos mechanically
    Device Description
    The following Jieying Microtools are made of glass capillary tubing. They range in sizes and have various degrees of beveled angles as necessary for each individual application. They are gamma radiated and tested for endotoxin and mouse embryo. These devices are assisted reproduction microtools/pipettes that are used in the laboratory to denude, micromanipulate, or hold human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. - a. Injection pipette; - b. Holding pipette; - c. Biopsy pipette; - d. Polar body biopsy pipette; - e. Denuding pipette; - f. Partial zona dissection (PZD) pipette; - g. Assisted hatching (AH) pipette.
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