510(k) K892068

TRT (ACUSON) NEEDLE GUIDE KIT, STERILE by Amedic USA — Product Code FCG

K892068 is an FDA 510(k) premarket notification submitted by Amedic USA for the device "TRT (ACUSON) NEEDLE GUIDE KIT, STERILE". The FDA issued a decision of Substantially Equivalent on August 4, 1989. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Amedic USA has at least 9 other 510(k) clearances on record.