510(k) K203024

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge by Pentax Of America, Inc. — Product Code GEH

K203024 is an FDA 510(k) premarket notification submitted by Pentax Of America, Inc. for the device "C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge". The FDA issued a decision of Substantially Equivalent on Nov 24, 2020. 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 43 other 510(k) clearances on record.