510(k) K011122

BALLPEN SPINAL NEEDLE W/WO INTRODUCER by Rusch Intl. — Product Code BSP

K011122 is an FDA 510(k) premarket notification submitted by Rusch Intl. for the device "BALLPEN SPINAL NEEDLE W/WO INTRODUCER". The FDA issued a decision of Substantially Equivalent on November 16, 2001. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Rusch Intl. has at least 10 other 510(k) clearances on record.