510(k) K261806

ERBECRYO 2 Cryosurgical Unit and Accessories by Erbe Elektromedizin GmbH — Product Code GEH

K261806 is an FDA 510(k) premarket notification submitted by Erbe Elektromedizin GmbH for the device "ERBECRYO 2 Cryosurgical Unit and Accessories". The FDA issued a decision of Substantially Equivalent on June 9, 2026. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Erbe Elektromedizin GmbH has at least 10 other 510(k) clearances on record.