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The NiTi Compression Anastomosis Ring (CAR) is intended for use throughout the alimentary tract for the creation of end-to-end, end-toside and side-to-side anastomoses in both open and laparoscopic surgeries. Once wound strength is sufficient to maintain the anastomosis, the NiTi Compression Anastomosis Ring is passed from the body.

The Compression Anastomosis Ring (CAR) device is a sterile single use device. The CAR provides a simple method for the creation circular compression anastomosis of the alimentary tract. After a period of 7-10 days, a compression-induced necrosis of the tissue sides underneath the ring occurs and the whole device, together with the necrosed tissue that was compressed by the rings, detaches and is naturally expelled with the stool.

This document is a 510(k) summary for the Compression Anastomosis Ring (CAR) and does not contain any information regarding acceptance criteria or a study proving device performance against such criteria. It details the device's classification, predicate device, intended use, and substantial equivalence claim based on validations and performance testing, including animal studies.

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