510(k) K892071

GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE by Amedic USA — Product Code KNW

K892071 is an FDA 510(k) premarket notification submitted by Amedic USA for the device "GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE". The FDA issued a decision of Substantially Equivalent on August 8, 1989. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Amedic USA has at least 9 other 510(k) clearances on record.