FDAnews Device Daily Bulletin

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.