510(k) K123606

CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE by Scion Medical Technologies, LLC — Product Code KNW

K123606 is an FDA 510(k) premarket notification submitted by Scion Medical Technologies, LLC for the device "CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE". The FDA issued a decision of Substantially Equivalent on Mar 1, 2013. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Scion Medical Technologies, LLC has 5 other 510(k) clearances on record.