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510(k) Data Aggregation

    K Number
    K162881
    Device Name
    Kitazato OPU Needles
    Manufacturer
    Kitazato Corporation
    Date Cleared
    2017-07-11

    (270 days)

    Product Code
    MQE,MOE
    Regulation Number
    884.6100
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K112492
    Why did this record match?
    Device Name :

    Kitazato OPU Needles

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Kitazato OPU Needles consisting of:

    • · Kitazato OPU Needle with Connection Tube (model number Type2)
    • · Kitazato OPU Reduced Needle (model number Type3)
    • · Kitazato OPU Two-Stage Reduced Needle (model number Type4)
      are intended to obtain oocytes from ovarian follicles.
    Device Description

    The Kitazato OPU Needles are single-use sterile devices that are used for ultrasound-guided transvaginal collection of oocytes from ovarian follicles.
    All of the Kitazato OPU Needle have a similar general design and device materials. All of the Kitazato OPU Needles are composed of a 304 stainless steel needle, acrylonitrile butadiene styrene (ABS) needle hub, PVC connection tube, and a silicone stopper that is used to connect to a collection tube and vacuum pump.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Kitazato OPU Needles, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    CriteriaAcceptance CriterionReported Device Performance
    Endotoxin
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