510(k) K120691

BRAIN PORT by Nico Corporation — Product Code GZT

K120691 is an FDA 510(k) premarket notification submitted by Nico Corporation for the device "BRAIN PORT". The FDA issued a decision of Substantially Equivalent on June 5, 2012. 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.