Skip to content

Force Argon II Argon Enhanced Electrosurgical System

by Valleylab, Inc.

510(k) K964636

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964636 Date11 Mar 1997ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Force Argon II Argon Enhanced Electrosurgical System is an electrosurgical unit designed for precise energy delivery in surgical procedures. It utilizes argon gas enhancement to improve control and precision during electrosurgical applications.

The system features gas flow control with a low flow rate designed to help prevent overpressurization in laparoscopic procedures, and includes audio and visual alarms that warn of overpressure conditions. It is compatible with a wide range of generators and argon accessories, and received FDA 510(k) clearance as substantially equivalent under product code GEI.

Other devices from Valleylab, Inc.

See all devices from Valleylab, Inc. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Force Argon II Argon Enhanced Electrosurgical System used for?

    The Force Argon II system is designed for precise energy delivery in surgical procedures, utilizing argon gas enhancement to improve control and precision during electrosurgical applications, particularly where enhanced tissue effect and reduced charring are beneficial.

  • How does the Force Argon II system prevent overpressure during laparoscopic procedures?

    The system includes gas flow control with a low flow rate setting specifically designed to help prevent overpressurization in laparoscopic procedures, combined with audio and visual alarms that warn users of overpressure conditions to enhance safety.

  • Is the Force Argon II system compatible with other equipment and accessories?

    Yes, the Force Argon II system is compatible with a wide range of electrosurgical generators and argon accessories, allowing integration into existing surgical setups and flexibility in device configuration for various procedural needs.