U.S. Surgical gets new 510 (k) for ABBI

January 22, 1997

U.S. Surgical of Norwalk, CT, has received an updated 510(k) clearancefor its ABBI breast biopsy system, which had been the subjectof Food and Drug Administration scrutiny last year (SCAN 6/19/96).FDA regulators claimed that ABBI's original 510(k) did

U.S. Surgical of Norwalk, CT, has received an updated 510(k) clearancefor its ABBI breast biopsy system, which had been the subjectof Food and Drug Administration scrutiny last year (SCAN 6/19/96).FDA regulators claimed that ABBI's original 510(k) did not allowthe company to market the device for breast biopsy applications,while U.S. Surgical claimed that it included breast biopsy datain the submission. The new 510(k), issued last month, resolvesthe dispute.