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The Full Core Biopsy System is intended to be used for soft tissue and tumor biopsy of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes. When used for breast biopsy, the product is for diagnosis only. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal of using standard surgical procedures.

The Full Core Biopsy System (the "System") includes an automatic spring powered Biopsy Device (the "Device") and a Coaxial Introducer (K954265, Promex Technologies, LLC) ("the Introducer"). As described more fully in the scientific concepts section below, the Device obtains and delivers a core tissue sample. The end-cut design of the Device allows the entire inner diameter of the cutting cannula to be open to capture tissue. The System (2 components) is comprised of; 1. The Device 2. The Introducer and are provided sterile in a pouch and intended for single patient use only. The System will be provided in 16, 18, and 20 gage and the working lengths range from 10cm to 25cm. The Device includes a Franseen-style cutting geometry on the end of the cannula and the Introducer includes a standard trocar tip.