510(k) K100520

NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER by Nipro Medical Corporation — Product Code FIE

K100520 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER". The FDA issued a decision of Substantially Equivalent on March 17, 2010. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Nipro Medical Corporation has at least 10 other 510(k) clearances on record.