510(k) K242625

Freeze Point & Private Label Versions by Cryoconcepts LP — Product Code GEH

K242625 is an FDA 510(k) premarket notification submitted by Cryoconcepts LP for the device "Freeze Point & Private Label Versions". The FDA issued a decision of Substantially Equivalent on October 25, 2024. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Cryoconcepts LP has at least 7 other 510(k) clearances on record.