APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets

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 found in the data synced 22 Oct 2026.

Trade Name

Apc 3 EUDAMED

Erbe GUDID

Generic Name

Argon-enhanced electrosurgical system gas delivery unit

Device Name

APC 3 Module

Model / Ref / Catalog

10135-000

Primary DI / UDI-DI

04050147015692

Basic UDI-DI

4050147APC3-G9

Direct Marketing DI

04050147015692

510(k) Number

K191234 ↗

FDA Product Code

GEI

EMDN Code

Z12010903 Argon electrosurgical units (esu)

GMDN Term

Argon-enhanced electrosurgical system gas delivery unit

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 878.4400

EU 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 can this integrated system support, and how does it differ from traditional electrosurgery?

  This system combines the APC 3 Argon Plasma Coagulation Unit and the VIO 3 Electrosurgical Unit to provide both precise tissue coagulation (via argon plasma) and cutting (via electrosurgery). It is designed for general, plastic, and specialty surgeries where controlled hemostasis and minimal tissue trauma are critical. Unlike traditional electrosurgery, which relies on direct contact with tissue, argon plasma coagulation allows for non-contact energy delivery, reducing thermal spread and improving precision—especially useful in minimally invasive procedures.

• Are the FiAPC probes, Hybrid APC, and APCapplicators single-use or reusable, and how is sterility ensured?

  The FiAPC probes, Hybrid APC, and APCapplicators are designed for either single-use or reusable applications, depending on the specific accessory. Sterility is maintained through manufacturer-provided packaging for single-use items or through established sterilization protocols (e.g., autoclave or ethylene oxide) for reusable components. Always follow the manufacturer’s guidelines to ensure proper sterilization and avoid cross-contamination.

• What accessories are included with the system, and how do they enhance surgical precision?

  The system includes FiAPC probes, Hybrid APC, APCapplicators, an APC Pressure Reducer with Sensor (for consistent gas flow control), a VIO Cart (for electrosurgical functionality), and fastening sets. These accessories work together to provide targeted coagulation, reduce thermal damage, and ensure stable energy delivery—critical for precision in procedures like laparoscopic or endoscopic surgeries where direct contact is limited.

• How does the APC Pressure Reducer with Sensor contribute to the safety and effectiveness of the system?

  The APC Pressure Reducer with Sensor regulates argon gas flow, ensuring consistent and controlled energy delivery during coagulation. This prevents excessive pressure variations that could lead to inconsistent tissue effects or gas leaks, enhancing both safety and the precision of hemostasis in surgical procedures.

• Is this system compatible with other Erbe devices, and what are the key regulatory pathways it follows?

  Yes, the system is designed to integrate with Erbe’s complementary equipment, such as the ERBEJET 2 water jet system, for expanded surgical capabilities. Regulatory-wise, it holds FDA 510(k) clearance under the General and Plastic Surgery advisory committees (K191234) and complies with the Medical Device Regulation (MDR), ensuring it meets both U.S. and EU standards for safety and performance.