510(k) K191780

AP50/30 Insufflator with Insuflow Port by Lexion Medical, LLC — Product Code HIF

K191780 is an FDA 510(k) premarket notification submitted by Lexion Medical, LLC for the device "AP50/30 Insufflator with Insuflow Port". The FDA issued a decision of Substantially Equivalent on August 28, 2019. 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.