A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

The Mammotome® Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The Mammotome® Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of a 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. aa ced U0 [) Ss (Division Bign-Off Division of General Restorative Devices ve @ Ks §10(k) Number ee AGL