510(k) K181007

Cianna Medical SAVI Scout Reflector and SAVI Scout System by Cianna Medical, Inc. — Product Code NEU

K181007 is an FDA 510(k) premarket notification submitted by Cianna Medical, Inc. for the device "Cianna Medical SAVI Scout Reflector and SAVI Scout System". The FDA issued a decision of Substantially Equivalent on August 2, 2018. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Cianna Medical, Inc. has at least 9 other 510(k) clearances on record.