510(k) K231580

NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) by Medtronic Xomed, Inc. — Product Code ETN

K231580 is an FDA 510(k) premarket notification submitted by Medtronic Xomed, Inc. for the device "NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)". The FDA issued a decision of Substantially Equivalent on August 30, 2023. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Medtronic Xomed, Inc. has at least 10 other 510(k) clearances on record.