510(k) K071482

STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 by Synergetics, Inc. — Product Code GXD

K071482 is an FDA 510(k) premarket notification submitted by Synergetics, Inc. for the device "STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000". The FDA issued a decision of Substantially Equivalent on December 20, 2007. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. Synergetics, Inc. has at least 10 other 510(k) clearances on record.