510(k) K210394

Electrosurgical accessory by Dornier Medtech America, Inc. — Product Code FAS

K210394 is an FDA 510(k) premarket notification submitted by Dornier Medtech America, Inc. for the device "Electrosurgical accessory". The FDA issued a decision of Substantially Equivalent on May 19, 2021. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Dornier Medtech America, Inc. has at least 10 other 510(k) clearances on record.