About This 510(k) Submission
K203024 is an FDA 510(k) clearance for the C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Pentax of America, Inc. (Redwood, Ca, US). The FDA issued a Cleared decision on November 24, 2020, 53 days after receiving the submission on October 2, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.