K190651 is an FDA 510(k) clearance for the ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Erbe Elektromedizin GmbH (Tuebingen, DE). The FDA issued a Cleared decision on January 7, 2020, 300 days after receiving the submission on March 13, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.