510(k) K063546

INSUFLOW DEVICE, MODEL 6198 by Lexion Medical, LLC — Product Code HIF

K063546 is an FDA 510(k) premarket notification submitted by Lexion Medical, LLC for the device "INSUFLOW DEVICE, MODEL 6198". The FDA issued a decision of Substantially Equivalent on January 10, 2007. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Lexion Medical, LLC has at least 10 other 510(k) clearances on record.