510(k) K150378

NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook by Nico Corporation — Product Code GZT

K150378 is an FDA 510(k) premarket notification submitted by Nico Corporation for the device "NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook". The FDA issued a decision of Substantially Equivalent on June 12, 2015. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Nico Corporation has at least 8 other 510(k) clearances on record.