510(k) K120002

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

K120002 is an FDA 510(k) premarket notification submitted by Busse Hospital Disposables, Inc. for the device "I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE". The FDA issued a decision of Substantially Equivalent on June 26, 2012. 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.