FDA clears new Biopsys 510(k) request

The Food and Drug Administration this month granted premarket notification clearance to a new 510(k) application filed by Biopsys Medical of Irvine, CA, for its Mammotome breast biopsy device. Biopsys filed the new 510(k) application on Feb. 12 as part of an agreement with the FDA to resolve labeling issues regarding Mammotome (SCAN 3/5/97). The agency's move allows Biopsys to market Mammotome for diagnostic breast biopsy applications.