510(k) K232227

ABLATE-IQ by Neuwave Medical, Inc. — Product Code JAK

K232227 is an FDA 510(k) premarket notification submitted by Neuwave Medical, Inc. for the device "ABLATE-IQ". The FDA issued a decision of Substantially Equivalent on April 4, 2024. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Neuwave Medical, Inc. has at least 10 other 510(k) clearances on record.