510(k) K192247

Steripath Gen2 Blood Collection System by Magnolia Medical Technologies, Inc. — Product Code JKA

K192247 is an FDA 510(k) premarket notification submitted by Magnolia Medical Technologies, Inc. for the device "Steripath Gen2 Blood Collection System". The FDA issued a decision of Substantially Equivalent on February 28, 2020. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Magnolia Medical Technologies, Inc. has at least 3 other 510(k) clearances on record.