510(k) K151041

ERBECRYO 2 Cryosurgical Unit with accessories by Erbe USA, Inc. — Product Code GEH

K151041 is an FDA 510(k) premarket notification submitted by Erbe USA, Inc. for the device "ERBECRYO 2 Cryosurgical Unit with accessories". The FDA issued a decision of Substantially Equivalent on May 4, 2015. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Erbe USA, Inc. has at least 10 other 510(k) clearances on record.