510(k) K253230

ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe by Erbe Elektromedizin GmbH — Product Code GEH

K253230 is an FDA 510(k) premarket notification submitted by Erbe Elektromedizin GmbH for the device "ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe". The FDA issued a decision of Substantially Equivalent on April 22, 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.