510(k) K102802

INTEGRA ELECTRODE TUNNELING NEEDLE by Integra LifeSciences Corporation — Product Code GYC

K102802 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "INTEGRA ELECTRODE TUNNELING NEEDLE". The FDA issued a decision of Substantially Equivalent on November 23, 2010. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.