510(k) K070360

KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 by Kirwan Surgical Products, Inc. — Product Code LFL

K070360 is an FDA 510(k) premarket notification submitted by Kirwan Surgical Products, Inc. for the device "KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601". The FDA issued a decision of Substantially Equivalent on August 7, 2007. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Kirwan Surgical Products, Inc. has at least 10 other 510(k) clearances on record.