510(k) K222865

M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle by Canyon Medical, Inc. — Product Code KNW

K222865 is an FDA 510(k) premarket notification submitted by Canyon Medical, Inc. for the device "M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle". The FDA issued a decision of Substantially Equivalent on April 3, 2023. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Canyon Medical, Inc. has at least 4 other 510(k) clearances on record.