510(k) K953923

URESIL INTRODUCING NEEDLE by Uresil Corp. — Product Code KNW

K953923 is an FDA 510(k) premarket notification submitted by Uresil Corp. for the device "URESIL INTRODUCING NEEDLE". The FDA issued a decision of Substantially Equivalent on September 8, 1995. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Uresil Corp. has at least 10 other 510(k) clearances on record.