510(k) K151968

Cryocare CS-3 Surgical System version 5 by Healthtronics — Product Code GEH

K151968 is an FDA 510(k) premarket notification submitted by Healthtronics for the device "Cryocare CS-3 Surgical System version 5". The FDA issued a decision of Substantially Equivalent on September 9, 2015. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Healthtronics has at least 3 other 510(k) clearances on record.