510(k) K230646

SUREcore Prime Biopsy Instrument by Uro-1 Medical, Inc. — Product Code KNW

K230646 is an FDA 510(k) premarket notification submitted by Uro-1 Medical, Inc. for the device "SUREcore Prime Biopsy Instrument". The FDA issued a decision of Substantially Equivalent on November 29, 2023. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075.