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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.

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.

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:

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The Kitazato OPU Needles consisting of:

• Kitazato OPU Needle with Connection Tube, model number Type 2
• . Kitazato OPU Reduced Needle, model number Type 3

are intended to obtain oocytes from ovarian follicles.

The Kitazato OPU Needles are intended to puncture into the vaginal wall and obtain oocytes from ovarian follicles. The OPU Needle with Connection Tube, model number Type 2, product consists of Aspiration Needle with Connection Tube and Silicone Stopper Connector. The OPU Reduced Needle, model number Type 3, product consists of Reduced Aspiration Needle with Connection Tube and Silicone Stopper Connector.

Here's a breakdown of the acceptance criteria and study information for the Kitazato OPU Needle based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device