510(k) K140263

INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT by Lexion Medical, LLC — Product Code HIF

K140263 is an FDA 510(k) premarket notification submitted by Lexion Medical, LLC for the device "INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT". The FDA issued a decision of Substantially Equivalent on March 5, 2014. 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.