510(k) K851364

FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP by Precision Dynamics Corp. — Product Code KNW

K851364 is an FDA 510(k) premarket notification submitted by Precision Dynamics Corp. for the device "FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP". The FDA issued a decision of Substantially Equivalent on April 22, 1985. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Precision Dynamics Corp. has at least 10 other 510(k) clearances on record.