510(k) K021595

GYRUS ENT NERVE STIMULATOR by Gyrus Ent LLC — Product Code ETN

K021595 is an FDA 510(k) premarket notification submitted by Gyrus Ent LLC for the device "GYRUS ENT NERVE STIMULATOR". The FDA issued a decision of Substantially Equivalent on October 24, 2002. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Gyrus Ent LLC has at least 10 other 510(k) clearances on record.