510(k) K061570

I-STYLE BONE MARROW ASPIRATION NEEDLE by Busse Hospital Disposables, Inc. — Product Code KNW

K061570 is an FDA 510(k) premarket notification submitted by Busse Hospital Disposables, Inc. for the device "I-STYLE BONE MARROW ASPIRATION NEEDLE". The FDA issued a decision of Substantially Equivalent on July 3, 2006. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Busse Hospital Disposables, Inc. has at least 10 other 510(k) clearances on record.