Home » FDA Grants 510(k) Clearance to Intact Medical for Breast Lesion Device
FDA Grants 510(k) Clearance to Intact Medical for Breast Lesion Device
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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