510(k) K012724

SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 by Smith & Nephew, Inc. — Product Code LYK

K012724 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273". The FDA issued a decision of Substantially Equivalent on November 8, 2001. The device falls under product code LYK (Angioscope), a Class II device regulated under 21 CFR 876.1500. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.