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AQUABOND Electrode

by Medibond, Ltd.

510(k) K964433

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 NumberK964433 Date27 Jan 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  • Withdrawn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
GXY
FDA applicant
Medibond , Ltd.
Device Class
Class II
Regulation
21 CFR Part 882.1320
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

The AQUABOND electrode is a disposable EEG cutaneous electrode that uses an aqueous, conductive adhesive to bond an Ag/AgCl disk to the skin. Because the adhesive is aqueous, removal is quick and unaccompanied by odors from organic solvents, as is the case with electrodes attached with pastes.

The device is supplied as a single-use electrode and is regulated as a Class 2 Neurology device with product code GXY. It was cleared through the Traditional 510(k) pathway after an 83-day FDA review. The electrode is designed for use in EEG procedures and is manufactured by Medibond, Ltd.

Questions

AI-generated answers, 24 Sep 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 AQUABOND electrode used for?

    The AQUABOND electrode is designed for use in EEG procedures as a disposable cutaneous electrode that bonds an Ag/AgCl disk to the skin using an aqueous, conductive adhesive.

  • How is the AQUABOND electrode supplied and is it reusable?

    The AQUABOND electrode is supplied as a single-use device and is intended for disposable use only, meaning it should not be reused after removal from the patient.

  • What makes the AQUABOND electrode different from other EEG electrodes?

    The AQUABOND electrode uses an aqueous, conductive adhesive instead of paste, allowing for quick removal without odors from organic solvents, which are common with traditional paste-attached electrodes.