510(k) K031482

CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE by Cryomedical Instruemts , Ltd. — Product Code GXH

K031482 is an FDA 510(k) premarket notification submitted by Cryomedical Instruemts , Ltd. for the device "CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE". The FDA issued a decision of Substantially Equivalent on July 10, 2003. The device falls under product code GXH (Device, Surgical, Cryogenic), a Class II device regulated under 21 CFR 882.4250.