# 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

- Pathway: 510(k) (Traditional)
- Applicant: Erbe Elektromedizin GmbH
- Decided: Jan 7, 2020 after 300 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 4 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K934261 (1994). 3 ancestors in all.
7 later devices descend from it; 6 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151041: ERBECRYO 2 Cryosurgical Unit with accessories, Erbe USA, Inc. (2015) Summary page 4.

## Most influential descendants
- K253230: ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe (2026), 1 descendant of its own
- K240932: HybridTherm System (2024), 1 descendant of its own
- K262420: Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) (2026), 0 descendants of its own
- K261068: Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) (2026), 0 descendants of its own
- K261806: ERBECRYO 2 Cryosurgical Unit and Accessories (2026), 0 descendants of its own

## Recalls of this device
- Jun 26, 2026 · Class II · Z-2938-2026: A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading 
- Feb 12, 2026 · Class I · Z-1568-2026: Probes may rupture/burst during activation
- Feb 12, 2026 · Class I · Z-1567-2026: Probes may rupture/burst during activation
- Feb 12, 2026 · Class I · Z-1566-2026: Probes may rupture/burst during activation

## 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/K190651
Methodology: https://510kreport.com/methodology