510(k) K213246

NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long by Medtronic Xomed, Inc. — Product Code ETN

K213246 is an FDA 510(k) premarket notification submitted by Medtronic Xomed, Inc. for the device "NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long". The FDA issued a decision of Substantially Equivalent on March 21, 2022. 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.