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Disposable Bipolar Electrode

by Neuro Navigational Corp. 2 variants

510(k) K942955

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 NumberK942955 Date3 Aug 1994ClearedStatusActive

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  • Withdrawn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
GWG
Device Class
Class II
Regulation
21 CFR Part 882.1480
Advisory Committee
Neurology
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 Disposable Bipolar Electrode is a single-use medical device designed for neurosurgical procedures. It delivers controlled electrical stimulation or coagulation during surgical interventions, facilitating tissue manipulation while minimizing damage to surrounding areas. This electrode is specifically engineered to provide precise bipolar energy application, reducing collateral thermal effects compared to monopolar systems.

Intended for use in sterile operating room environments, the Disposable Bipolar Electrode is supplied as a single-patient-use item to ensure hygiene and prevent cross-contamination. It is classified as a Class II device under FDA regulations (product code GWG) and has received FDA 510(k) clearance (K942955) through the Traditional pathway. The device is non-magnetic and compatible with MRI environments when used as intended. Storage requires protection from moisture and physical damage, adhering to standard sterile medical device handling protocols.

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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 Disposable Bipolar Electrode used for in neurosurgery?

    The Disposable Bipolar Electrode is designed for neurosurgical procedures to deliver controlled electrical stimulation or coagulation. This helps surgeons manipulate tissue while minimizing damage to surrounding areas, thanks to its precise bipolar energy application which reduces collateral thermal effects compared to monopolar systems.

  • Is the Disposable Bipolar Electrode reusable or single-use?

    The Disposable Bipolar Electrode is explicitly designed for single-patient use. This ensures hygiene and prevents cross-contamination, which is critical in sterile operating room environments where infection control is paramount.

  • How should the Disposable Bipolar Electrode be stored?

    Storage requires protection from moisture and physical damage. It must adhere to standard sterile medical device handling protocols to maintain its integrity and ensure it remains ready for use in surgical settings.

  • Can the Disposable Bipolar Electrode be used in MRI environments?

    Yes, the Disposable Bipolar Electrode is non-magnetic and compatible with MRI environments when used as intended. This makes it suitable for neurosurgical procedures where MRI imaging may be required.

  • What regulatory pathway was followed for FDA clearance of this device?

    The Disposable Bipolar Electrode received FDA 510(k) clearance through the Traditional pathway. It is classified as a Class II device under FDA regulations with product code GWG, and the clearance number is K942955.