510(k) K212786

LevaLap Laparoscopic Access Device by Core Access Surgical Technologies, Inc. — Product Code HIF

K212786 is an FDA 510(k) premarket notification submitted by Core Access Surgical Technologies, Inc. for the device "LevaLap Laparoscopic Access Device". The FDA issued a decision of Substantially Equivalent on February 23, 2022. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730.