510(k) K890926

SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE by Meadox Surgimed, Inc. — Product Code FMI

K890926 is an FDA 510(k) premarket notification submitted by Meadox Surgimed, Inc. for the device "SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE". The FDA issued a decision of Substantially Equivalent on June 20, 1989. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Meadox Surgimed, Inc. has at least 10 other 510(k) clearances on record.