G210 InviCell Plus with SignipHy pH monitoring

G210 InviCell Plus with SignipHy pH monitoring is an FDA 510(k)-cleared medical device (K191020) manufactured by CooperSurgical, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 13, 2020. Regulation: 8.