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

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• • Ongoing Z-2938-2026 FDA Class II ·initiated 26 Jun 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 to excessive pressure causing the cryoprobe to rupture.

• 3 recalls, same reason

  • Ongoing Z-1566-2026 FDA Class I ·initiated 12 Feb 2026
  • Ongoing Z-1568-2026 FDA Class I ·initiated 12 Feb 2026
  • Ongoing Z-1567-2026 FDA Class I ·initiated 12 Feb 2026

  Probes may rupture/burst during activation

Trade Name

Adapter

Device Name

Electrosurgical adapter

Model / Reference

20183-100, 20183-101

Primary DI / UDI-DI

04050147020481, 04050147020498

Basic UDI-DI

4050147Adapter-HF-M6

Direct Marketing DI

04050147020481

04050147020498

510(k) Number

K190651 ↗

FDA Product Code

GEH

EMDN Code

K020180 Single- and bipolar devices, single use - accessories

Models / Variants

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

Device Class

Class I EUDAMED

Class II 510(k)

Regulation

21 CFR Part 878.4350

EU market of registration

Germany

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Kugelelektrode; ø 3mm

  Class IIb

  CE/MDR

• Einmal-Elektrodengriff

  Class IIb

  CE/MDD

• Halterung

  Class IIb

  CE/MDR

• Schlingenelektr. Wolfr.; ø15mm

  Class IIb

  CE/MDR

• Bipolare Pinzette Premium

  Class IIb

  CE/MDR

• Neutralelektroden Kabel

  Class I

  CE/MDR

See all devices from Erbe Elektromedizin GmbH →

• What types of surgical procedures is the ERBECRYO 2 Cryosurgical Unit primarily intended for, and how does it provide versatility in application?

  The ERBECRYO 2 is designed for controlled tissue freezing in both general and plastic surgery, enabling targeted treatment through three freezing techniques: en face (flat surface), tangential (angled), and circumferential (360°). This versatility allows clinicians to adapt the device to various surgical needs, such as skin lesion removal, tissue reshaping, or nerve preservation, depending on the probe placement and freezing pattern selected.

• Is the ERBECRYO 2 system reusable, and if so, what components require sterilization before each use?

  Yes, the ERBECRYO 2 is supplied as a reusable medical device, meaning the main unit, footswitch, cart (including the VIO-Cart and wire basket), connecting hoses, switching valves, and adapters are designed for repeated use. However, the flexible cryoprobes—which make direct contact with tissue—must be treated as single-use items or sterilized rigorously between procedures, as per standard sterile surgical protocols for reusable medical devices.

• How do I ensure proper storage of the ERBECRYO 2 Cryosurgical Unit and its accessories to maintain functionality and sterility?

  The device and its reusable components (e.g., cart, footswitch, hoses) should be stored in a clean, dry environment protected from dust, moisture, and extreme temperatures, following standard sterile medical device protocols. Single-use cryoprobes, if not immediately used post-sterilization, should be stored according to manufacturer guidelines—typically in sealed, sterile packaging until deployment. Always refer to the included instructions for storage conditions specific to each accessory.

• What regulatory pathways has the ERBECRYO 2 followed for market authorization, and which agencies have approved its use?

  The ERBECRYO 2 has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) compliance in the EU, confirming its substantial equivalence to prior-generation devices and adherence to safety/performance standards. These pathways ensure the device meets regulatory requirements for cryosurgical applications in both markets, though actual availability depends on local healthcare system approvals.

• Are there different probe sizes or models available for the ERBECRYO 2, and how do I determine which one is best for my procedure?

  The system includes multiple flexible cryoprobes (specific sizes/models listed under FEI numbers in the data), each designed for distinct clinical applications—such as superficial skin treatments or deeper tissue ablation. The choice depends on the target tissue area, freezing pattern (en face/tangential/circumferential), and surgeon preference. Consult the device’s technical documentation or contact Erbe Elektromedizin GmbH for guidance on selecting the appropriate probe based on your procedure’s requirements.