Valleylab Current Monitor, E3350 & E3351

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K926415 ↗

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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  FDA 510(k) K884412 Active Cleared 2 Dec 1988

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  FDA 510(k) K942579 Active Cleared 21 Sep 1994

See all devices from Valleylab, Inc. →

• What is the Valleylab Current Monitor E3350 & E3351 used for?

  The Valleylab Current Monitor E3350 & E3351 is an electrosurgical accessory designed for cutting and coagulation during surgical procedures. It functions as part of an electrosurgical system to monitor current delivery, helping ensure consistent energy output for tissue effects in general and plastic surgery settings.

• How is the Valleylab Current Monitor E3350 & E3351 supplied or configured for use?

  The device is supplied as a standalone accessory unit (models E3350 and E3351) intended to interface with electrosurgical generators. It does not include electrodes or cables unless specified separately; its role is to monitor and provide feedback on current flow within the surgical circuit to support safe and effective energy delivery.

• Is the Valleylab Current Monitor E3350 & E3351 intended for single-use or reusable applications?

  Based on its design as an electronic monitoring accessory and the absence of any indication of disposability or single-use labeling in the provided data, the Valleylab Current Monitor E3350 & E3351 is intended for reusable use. It is built for repeated connection to electrosurgical systems across multiple procedures, subject to proper cleaning and maintenance per manufacturer guidelines.