510(k) K212814

C2 CryoBalloon Ablation System by Pentax of America, Inc. — Product Code GEH

K212814 is an FDA 510(k) premarket notification submitted by Pentax of America, Inc. for the device "C2 CryoBalloon Ablation System". The FDA issued a decision of Substantially Equivalent on November 29, 2021. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Pentax of America, Inc. has at least 10 other 510(k) clearances on record.