Force 4B Electrosurgical Generator

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

Full name

Model Force 4B Electrosurgical Generator

510(k) Number

K864675 ↗

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 Valleylab, Inc. →

• Is the Valleylab Model Force 4B Electrosurgical Generator designed for single-use or reusable applications in the operating room? Why does this matter?

  The Model Force 4B is explicitly described as a reusable medical instrument, meaning it is built for repeated use in surgical settings after proper cleaning, disinfection, and maintenance. This matters because reusable devices require a robust sterilization protocol (e.g., autoclave or chemical sterilization) to ensure patient safety between procedures, whereas single-use devices eliminate this risk entirely but incur higher per-procedure costs. Since it’s reusable, your facility must have validated reprocessing procedures in place.

• What types of surgical procedures or tissue manipulations can this device perform, and how does its REM feature enhance safety?

  The Model Force 4B provides cutting, coagulation, and blend modes, which allow surgeons to precisely manipulate tissue during procedures like general surgery, plastic surgery, or other electrosurgical applications. The integrated REM (Return Electrode Monitoring) feature actively monitors the patient’s return electrode (ground pad) to detect disconnections or improper placement, reducing the risk of burns or unintended tissue damage. This is critical for patient safety during prolonged or complex procedures.

• How is the Model Force 4B Electrosurgical Generator supplied, and are there any special handling or storage requirements mentioned?

  The device is supplied as a reusable medical instrument, meaning it is not pre-sterilized or packaged for single-use. Since no specific sterility or storage instructions are provided in the data, your facility should follow standard protocols for electrosurgical generators, including protection from moisture, electrostatic discharge, and physical damage. Ensure it is stored in a clean, dry environment when not in use, and follow manufacturer guidelines for maintenance to preserve functionality.

• What regulatory pathway was followed for FDA clearance of this device, and what does the ‘GEI’ product code indicate?

  The Model Force 4B received FDA 510(k) clearance (K864675) under the product code GEI, which stands for *Electrosurgical Units, Monopolar and Bipolar*. The clearance was granted under the Traditional 510(k) review pathway, meaning the manufacturer demonstrated that their device is substantially equivalent to a legally marketed predicate device (in this case, evaluated by the Surgical Units (SU) Advisory Committee). The ‘GEI’ code confirms this device falls under electrosurgical generators, not other surgical tools.