510(k) K241045

Disposable Subdermal Needle Electrode, Corkscrew by Technomed Europe — Product Code GXZ

K241045 is an FDA 510(k) premarket notification submitted by Technomed Europe for the device "Disposable Subdermal Needle Electrode, Corkscrew". The FDA issued a decision of Substantially Equivalent on December 11, 2024. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Technomed Europe has at least 10 other 510(k) clearances on record.