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Active Electrode Monitoring System

by Electroscope, Inc.

510(k) K000480

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK000480 Date2 May 2000ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1052-03 FDA Unclassified (pre-2012) initiated 23 Jun 2003
    • Terminated Z-1050-03 FDA Unclassified (pre-2012) initiated 23 Jun 2003
    • Terminated Z-1051-03 FDA Unclassified (pre-2012) initiated 23 Jun 2003

    Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.

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  • Withdrawn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, 1 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 Active Electrode Monitoring System is a medical device classified under the General & Plastic Surgery category (Product Code: GEI). It is designed to monitor the electrical activity of active electrodes during surgical procedures, ensuring safe and effective use of electrosurgical equipment. This system helps prevent unintended activation of electrodes, reducing the risk of patient injury or complications. It is intended for use in operating rooms and surgical settings where electrosurgery is performed.

This device is supplied as a reusable system and requires proper maintenance and calibration to ensure accurate monitoring. It is not intended for MRI environments, as its functionality may be compromised by magnetic fields. The system is authorized under an FDA 510(k) clearance (K000480) and is regulated as a Class II device under the General & Plastic Surgery category. Storage and handling must comply with manufacturer guidelines to preserve performance and safety.

Other devices from Electroscope, Inc.

Questions

AI-generated answers, 1 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 Active Electrode Monitoring System used for?

    The Active Electrode Monitoring System is designed to monitor electrical activity from active electrodes during surgical procedures involving electrosurgery. It helps prevent accidental activation of electrodes, which can reduce the risk of patient injury or complications by ensuring safe and controlled use of electrosurgical equipment in operating rooms.

  • Is the Active Electrode Monitoring System reusable or single-use?

    The Active Electrode Monitoring System is supplied as a reusable device. It requires proper maintenance and calibration to ensure accurate monitoring and continued functionality over multiple uses.

  • Can this system be used in MRI environments?

    No, the Active Electrode Monitoring System is not intended for use in MRI environments. Its functionality may be compromised by magnetic fields, which could interfere with its performance and safety.

  • What regulatory clearance does this device have?

    The Active Electrode Monitoring System holds an FDA 510(k) clearance (K000480) and is classified as a Class II device under the General & Plastic Surgery category (Product Code: GEI). This clearance confirms it meets regulatory standards for safety and effectiveness.

  • How should the Active Electrode Monitoring System be stored?

    Storage and handling of the Active Electrode Monitoring System must follow the manufacturer’s guidelines to maintain performance and safety. Proper storage conditions help preserve functionality and ensure the device operates reliably during surgical procedures.