510(k) K171531

Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle by Care Fusion — Product Code KNW

K171531 is an FDA 510(k) premarket notification submitted by Care Fusion for the device "Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle". The FDA issued a decision of Substantially Equivalent on September 11, 2017. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Care Fusion has at least 10 other 510(k) clearances on record.