Erbe ESU Model VIO 3n with Accessories

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

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

No FDA recalls on record, checked 23 Oct 2026.

Trade Name

VIO® 3n EUDAMED

Erbe GUDID

Generic Name

Electrosurgical system generator

Device Name

VIO® 3n Electrosurgical unit

Model / Reference

10160-010

Primary DI / UDI-DI

04050147023741

Basic UDI-DI

4050147VIO3n-P9

Direct Marketing DI

04050147023741

510(k) Number

K251108 ↗

FDA Product Code

GEI

EMDN Code

Z12010902 Electrosurgical units (esu) for general use

GMDN Term

Electrosurgical system generator

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 878.4400

Market of Registration

Germany

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• 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 Erbe ESU Model VIO® 3n primarily intended to support, and how does it achieve its effects?

  The Erbe ESU Model VIO® 3n is designed for general, plastic, and reconstructive surgeries, where precise tissue dissection, coagulation, and cutting are required. It delivers controlled radiofrequency energy to achieve hemostasis (stopping bleeding) and tissue separation, enabling surgeons to perform these tasks with accuracy in sterile environments.

• Is the Erbe ESU Model VIO® 3n a single-use or reusable device, and what sterilization requirements apply?

  The Erbe ESU Model VIO® 3n is a reusable medical instrument, meaning it must undergo proper sterilization between uses to maintain safety and functionality. Sterilization should follow established protocols for reusable electrosurgical units to ensure it remains free of contamination for subsequent procedures.

• What regulatory pathways has the Erbe ESU Model VIO® 3n followed, and what does this mean for its use in clinical settings?

  The device has received FDA 510(k) clearance under the product code GEI (Electrosurgical Units) and MDR authorization, confirming it meets regulatory standards for safety and performance. This means it can be legally marketed and used in the U.S. and EU, provided it is operated by trained personnel in compliance with manufacturer guidelines and local regulations.

• Does the Erbe ESU Model VIO® 3n include accessories, and how do these enhance its functionality?

  Yes, the Erbe ESU Model VIO® 3n is supplied with accessories tailored for various surgical applications. These accessories likely include electrodes, cables, and other tools that enable precise energy delivery for cutting, coagulation, or blending—depending on the specific procedure—thereby expanding the device’s versatility in different surgical contexts.

• Who should operate the Erbe ESU Model VIO® 3n, and what training or environment is required?

  The device must be operated by trained personnel familiar with electrosurgical techniques and safety protocols. Since it is used in sterile environments during surgeries, proper training ensures correct handling, energy settings, and adherence to infection control measures to prevent complications or equipment damage.