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The Rabbit is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. 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 using standard surgical procedures.

The Candidate Device is a coaxial breast biopsy system, which is intended to retrieve tissue samples from the breast for histological analysis .The device is provided sterile for single use only. The system includes a disposable biopsy device, Localization needle, stylet, and hook wire. The biopsy device includes a circular scalpel and a Garrote wire to transect the specimen.

The Scion Balloon Elevator is designed for endoscoopic surgery involved in extraperitoneal or subcutaneous spaces in such common procedures as Saphenous Vein Harvest. The Balloon elevator is designed to fit on the end of our Endoscope Retractor (510K #93006) and atraumatically provide support for the distal end of the retractor. The other function of the balloon is to gently spread tissue by the inflation of the balloon.

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The indications for the use of the DuoClip Titanium Clips are the same as those for a Hemostatic Clips (Product Code 79MCH, Class1, Regulation# 878.4300). The indications is for ligating blood vessels.

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