510(k) K153004

Clear Guide SCENERGY by Clear Guide Medical — Product Code JAK

K153004 is an FDA 510(k) premarket notification submitted by Clear Guide Medical for the device "Clear Guide SCENERGY". The FDA issued a decision of Substantially Equivalent on February 12, 2016. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Clear Guide Medical has at least 5 other 510(k) clearances on record.