510(k) K062478

CLAVIS by Medtronic A/S — Product Code BXN

K062478 is an FDA 510(k) premarket notification submitted by Medtronic A/S for the device "CLAVIS". The FDA issued a decision of Substantially Equivalent on February 8, 2007. The device falls under product code BXN (Stimulator, Nerve, Battery-Powered), a Class II device regulated under 21 CFR 868.2775. Medtronic A/S has at least 10 other 510(k) clearances on record.