ERBECRYO 2 Cryosurgical Unit and Flexible Cryoprobe

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

Full name

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

Trade Name

Flexible Cryoprobe EUDAMED

Erbe GUDID

Generic Name

Endoscopic cryosurgical probe, single-use

Device Name

Cryosurgery flex. probes, SU

Model / Ref / Catalog

20402-411

Primary DI / UDI-DI

04050147021839

Basic UDI-DI

4050147CryoProbe-SU-VT

Direct Marketing DI

04050147021839

510(k) Number

K253230 ↗ 510(k)

K190651 ↗ GUDID

FDA Product Code

GEH

EMDN Code

Z120102 Cryosurgery equipment

GMDN Term

Endoscopic cryosurgical probe, single-use

Models / Variants

ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit

Erbe Flexible Cryoprobe

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 878.4350

EU market of registration

Germany

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

Size

Length — 1150 Millimeter

• 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 tissues or conditions is the ERBECRYO 2 system primarily used to treat in surgical settings?

  The ERBECRYO 2 Cryosurgical Unit is designed for controlled tissue freezing to destroy abnormal tissues such as tumors or benign lesions. It is specifically authorized for use in general and plastic surgery applications, where cryoablation is employed to target and eliminate unwanted tissue through rapid freezing and thawing cycles.

• How is the ERBECRYO 2 system supplied, and are the cryoprobes reusable or single-use?

  The ERBECRYO 2 system is supplied as a reusable cryosurgical unit paired with single-use flexible cryoprobes. This setup ensures sterile conditions for each procedure while allowing the main unit to be reused across multiple applications, reducing operational costs and waste.

• Does the ERBECRYO 2 system include multiple probe sizes, and if so, what are the key considerations for selecting the right one?

  Yes, the ERBECRYO 2 system includes multiple probe sizes to accommodate different clinical needs. The selection of the appropriate probe size depends on the specific anatomical location and the size of the tissue targeted for ablation. The flexible design of the probes allows for precise delivery in various surgical settings, including areas where rigid probes may be less effective.

• What regulatory pathways has the ERBECRYO 2 system undergone, and what does this mean for its use in clinical environments?

  The ERBECRYO 2 system has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming its compliance with regulatory standards for cryosurgical interventions. This means the device has been evaluated for safety and effectiveness, allowing authorized use in clinical environments where controlled tissue freezing is required, such as in general and plastic surgery.

• Are there any special considerations for storing or handling the ERBECRYO 2 system and its accessories?

  While the device data does not specify storage conditions, the system is designed for use in sterile operating room environments. The single-use cryoprobes must be handled under sterile conditions to prevent contamination. The reusable cryosurgical unit should be cleaned and maintained according to manufacturer guidelines to ensure proper functionality and longevity, particularly given its intended use in surgical settings.