# K253230: ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe

- Pathway: 510(k) (Traditional)
- Applicant: Erbe Elektromedizin GmbH
- Decided: Apr 22, 2026 after 205 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K934261 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190651: 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, Erbe Elektromedizin GmbH (2020) Summary page 5.

## Most influential descendants
- K261806: ERBECRYO 2 Cryosurgical Unit and Accessories (2026), 0 descendants of its own

## Indications for use
The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion and devitalization (destruction) of tissue by the application of extreme cold. The Erbe Flexible Cryoprobes are intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies.

Source page: https://510kreport.com/device/K253230
Methodology: https://510kreport.com/methodology