510(k) K212355

Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large by Checkpoint Surgical — Product Code ETN

K212355 is an FDA 510(k) premarket notification submitted by Checkpoint Surgical for the device "Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large". The FDA issued a decision of Substantially Equivalent on August 26, 2021. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820.