510(k) K112178

JMS APHERESIS NEEDLE SET WINGEATER(R) V2 by JMS North America Corporation — Product Code FIE

K112178 is an FDA 510(k) premarket notification submitted by JMS North America Corporation for the device "JMS APHERESIS NEEDLE SET WINGEATER(R) V2". The FDA issued a decision of Substantially Equivalent on October 27, 2011. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. JMS North America Corporation has at least 8 other 510(k) clearances on record.