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The Cook Injection Needles are used to deliver a variety of injectable materials into tissues during laparoscopic, hysteroscopic, cystoscopic transurethral procedures and open surgical procedures. The type of material to be injected will be dependent on the nature of the procedure. The needle is intended to be used with legally marketed drugs and devices.

The Cook Injection Needle will consist of a Polyurethane Catheter with a Stainless Steel Needle Tip and a luer lock hub. The Catheter sizes range from 3.7 French to 9 French and will be 15cm to 65cm's in length. The Stainless Steel Needle portion will be 16 Gage though 25 Gage.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a medical device.

The provided text is a 510(k) Premarket Notification for "Cook Injection Needles." It focuses on establishing substantial equivalence to predicate devices based on indications for use, materials, and physical construction. It does not contain any data from a performance study or details about acceptance criteria for such a study.

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