510(k) K213232

NovaCore Semi-Automatic Biopsy Instrument by Argon Medical Devices — Product Code KNW

K213232 is an FDA 510(k) premarket notification submitted by Argon Medical Devices for the device "NovaCore Semi-Automatic Biopsy Instrument". The FDA issued a decision of Substantially Equivalent on July 1, 2022. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Argon Medical Devices has at least 10 other 510(k) clearances on record.