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FDA Grants 510(k) Clearance to Intact Medical for Breast Lesion Device
Sept. 17, 2008
Intact Medical received FDA 510(k) clearance for its Excise XL wand, a larger version of the company’s approved wands, for use with its Breast Lesion Excision System. In a minimally invasive procedure, the slender wand is inserted through a small incision in the breast to remove an intact sample of suspicious tissue for histopathologic analysis. It can extract larger breast tissues than previous wands, giving it potential to provide a more accurate histopathologic assessment and the complete excision of larger suspicious lesions, the company said.
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