510(k) K132463

CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM by Cianna Medical, Inc. — Product Code NEU

K132463 is an FDA 510(k) premarket notification submitted by Cianna Medical, Inc. for the device "CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on December 3, 2013. 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.