510(k) K243677

iovera° System by Pacira Biosciences, Inc. — Product Code GXH

K243677 is an FDA 510(k) premarket notification submitted by Pacira Biosciences, Inc. for the device "iovera° System". The FDA issued a decision of Substantially Equivalent on December 26, 2024. The device falls under product code GXH (Device, Surgical, Cryogenic), a Class II device regulated under 21 CFR 882.4250. Pacira Biosciences, Inc. has at least 1 other 510(k) clearance on record.