510(k) K012224

SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW by Ranfac, Corp. — Product Code KNW

K012224 is an FDA 510(k) premarket notification submitted by Ranfac, Corp. for the device "SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW". The FDA issued a decision of Substantially Equivalent on August 22, 2001. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Ranfac, Corp. has at least 10 other 510(k) clearances on record.