Soring GmbH, Arco 3000, Arco 2000, Arco 1000, Mbc 601, Mbc 600

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K993265 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Cpc by Soring GmbH

  Class II

  FDA 510(k) K030028 Active Cleared 17 Jan 2003

• Soring GmbH Sonoca Lipo

  Class II

  FDA 510(k) K052183 Active Cleared 7 Oct 2005

• Soring MBC200/BCC140

  Class II

  FDA 510(k) K093511 Active Cleared 16 Apr 2010

• Soring GmbH Sonoca 180/190

  Unclassified

  FDA 510(k) K012753 Active Cleared 13 Nov 2001

• Mbc Series

  Class II

  FDA 510(k) K024059 Active Cleared 8 Jan 2003

• Soring GmbH, Sonoca 300

  Class II

  FDA 510(k) K992026 Active Cleared 23 Sep 1999

• What types of surgical procedures are these electrosurgical units primarily intended for?

  These units (Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600) are designed for general and plastic surgery procedures, specifically for delivering radiofrequency energy via argon gas coagulation to cut or coagulate tissue. The argon gas beam allows for precise surgical control, making them suitable for applications where tissue interaction must be carefully managed.

• Are these devices single-use or reusable, and what sterilization steps are required?

  These electrosurgical units are reusable medical devices and are not sterile upon delivery. They must be sterilized prior to use following standard medical device sterilization protocols to ensure safety and efficacy in surgical settings.

• How do I determine which model is right for my surgical needs?

  Each model (Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600) is individually designed, but the key differentiator lies in their adjustable power output via electrodes, which ensures effective tissue interaction. The selection should be based on your specific surgical requirements, such as the type of tissue being treated and the precision needed. Consult your manufacturer’s guidelines or a surgical specialist to match the model to your clinical workflow.

• Can these devices be used in an MRI environment, and why or why not?

  No, these electrosurgical units are MRI-unsafe. The devices are not designed to be compatible with MRI environments, so they should only be used in settings where MRI procedures are not performed simultaneously or nearby. Always ensure the surgical area adheres to MRI safety protocols when using these units.

• What regulatory pathway was followed for FDA clearance, and what does that mean for my facility?

  These devices received FDA 510(k) clearance (K993265) under the product code GEI (Electrosurgical Cutting and Coagulating Devices) and were deemed substantially equivalent to a predicate device. The clearance was granted through a Special review type by the General and Plastic Surgery advisory committee. This means the device meets FDA standards for safety and effectiveness as determined by the regulatory process, but your facility should still follow local protocols for device validation and integration into surgical workflows.