510(k) K113771

SIGNAL GEAR URETHRAL CATHETER ELECTRODE by Neurovision Medical Products, Inc. — Product Code FAP

K113771 is an FDA 510(k) premarket notification submitted by Neurovision Medical Products, Inc. for the device "SIGNAL GEAR URETHRAL CATHETER ELECTRODE". The FDA issued a decision of Substantially Equivalent on December 13, 2012. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Neurovision Medical Products, Inc. has at least 8 other 510(k) clearances on record.