Valleylab Return Electrode Monitor

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

510(k) Number

K801153 ↗

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. →

• What is the primary function of the Valleylab Return Electrode Monitor?

  This device is designed to monitor the connection between the patient and the return electrode during electrosurgical procedures. By ensuring the integrity of the return path, it supports the safe delivery of electrosurgical energy to the patient.

• In which clinical environments is this device used?

  The Valleylab Return Electrode Monitor is intended for use in general and plastic surgery settings. It is supplied as a component of the electrosurgical system to assist clinicians in maintaining safe energy delivery during these specific types of procedures.

• What is the regulatory status of this device?

  The Valleylab Return Electrode Monitor is authorized under FDA 510K clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices for the same intended use.