510(k) K102460

AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH by Summit Medical Products, Inc. — Product Code BSO

K102460 is an FDA 510(k) premarket notification submitted by Summit Medical Products, Inc. for the device "AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH". The FDA issued a decision of Substantially Equivalent on January 13, 2011. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120. Summit Medical Products, Inc. has at least 3 other 510(k) clearances on record.