510(k) K972595

ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER by Avid N.I.T., Inc. — Product Code BSP

K972595 is an FDA 510(k) premarket notification submitted by Avid N.I.T., Inc. for the device "ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER". The FDA issued a decision of Substantially Equivalent on May 20, 1998. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Avid N.I.T., Inc. has at least 8 other 510(k) clearances on record.