510(k) K233031

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

K233031 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 January 17, 2024. 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.