Certas Plus Programmable Valves

About This 510(k) Submission

K223330 is an FDA 510(k) clearance for the Certas Plus Programmable Valves, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Integra Lifesciences Production Corporation (Mansfield, US). The FDA issued a Cleared decision on February 1, 2023, 93 days after receiving the submission on October 31, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.