510(k) K101320

VASOVAPOR by Lexion Medical, LLC — Product Code HIF

K101320 is an FDA 510(k) premarket notification submitted by Lexion Medical, LLC for the device "VASOVAPOR". The FDA issued a decision of Substantially Equivalent on June 24, 2010. 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.