# K261806: ERBECRYO 2 Cryosurgical Unit and Accessories

- Pathway: 510(k) (Special)
- Applicant: Erbe Elektromedizin GmbH
- Decided: Jun 9, 2026 after 8 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: 5 generations back to K934261 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
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.
- K253230: ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe, Erbe Elektromedizin GmbH (2026) Summary page 5.

## 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.

Source page: https://510kreport.com/device/K261806
Methodology: https://510kreport.com/methodology