510(k) K240457

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

K240457 is an FDA 510(k) premarket notification submitted by Pentax of America, Inc. for the device "C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)". The FDA issued a decision of Substantially Equivalent on July 24, 2024. 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.