510(k) K252681

EnCor EnCompass™ Breast Biopsy and Tissue Removal System by Bard Peripheral Vascular, Inc. — Product Code KNW

K252681 is an FDA 510(k) premarket notification submitted by Bard Peripheral Vascular, Inc. for the device "EnCor EnCompass™ Breast Biopsy and Tissue Removal System". The FDA issued a decision of Substantially Equivalent on December 12, 2025. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Bard Peripheral Vascular, Inc. has at least 10 other 510(k) clearances on record.