Erbe Esu Model Vio 100 C with Accessories

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K101108 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Erbe USA, Inc. →

• What types of surgical procedures is the Erbe VIO 100 C electrosurgical generator primarily used for?

  The Erbe VIO 100 C is designed for monopolar cutting, monopolar coagulation, and bipolar coagulation procedures. These modes allow precise tissue management through controlled electrical energy delivery, making it suitable for general surgical applications where careful tissue dissection or sealing is required, such as in plastic surgery or other specialty outpatient settings.

• Is the Erbe VIO 100 C intended for single-use or reusable applications, and what does that mean for maintenance?

  The Erbe VIO 100 C can be used in both single-use and reusable settings, depending on the specific accessories paired with it. If used in a reusable context, proper cleaning, sterilization, and maintenance of the device and accessories are required to ensure safety and functionality. Always follow manufacturer guidelines for reuse to avoid compromising performance or regulatory compliance.

• What accessories come included with the Erbe VIO 100 C, and how does this affect its versatility?

  The Erbe VIO 100 C is supplied with three socket modules, system software, a power cord, and an instruction manual. These socket modules allow for compatibility with various electrosurgical accessories, enhancing its versatility for different surgical techniques, such as cutting, coagulation, or blending, depending on the chosen attachments.

• Can the Erbe VIO 100 C be used in an MRI environment, and why might that be important for a facility?

  No, the Erbe VIO 100 C is explicitly stated as *not* MRI-compatible. This is important because using electrosurgical units in an MRI environment can pose significant safety risks, including interference with the MRI machine or potential harm to patients due to electromagnetic interactions. Facilities with MRI capabilities must ensure this device is used only in non-MRI areas.

• What regulatory pathway was followed for FDA clearance of the Erbe VIO 100 C, and what does that mean for its intended use?

  The Erbe VIO 100 C received FDA clearance through a 510(k) submission (K101108) under the product code GEI, which classifies it as an electrosurgical unit. The clearance was determined to be *substantially equivalent* to a predicate device, meaning it was evaluated for safety and effectiveness based on existing standards. This pathway confirms its compliance with U.S. regulatory requirements for electrosurgical generators, ensuring it meets established performance criteria for monopolar and bipolar procedures.