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Ellman Noble Alloy Electrodes

by Ellman International, Inc.

510(k) K071343

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 NumberK071343 Date28 Feb 2008ClearedStatusActive

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  • Withdrawn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, 25 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 Ellman Noble Alloy Electrodes are electrosurgical accessories used with electrosurgical generators. They consist of various electrode shapes, including loop, needle, ball, fine wire, tapered ball, and VariTip, fabricated from a noble alloy.

The electrodes are supplied in different designs and sizes. They are classified under the regulation 878.4400, with a product code of GEI, and have been found to be substantially equivalent. The device has an FDA 510(k) authorization, with the clearance type being traditional, and the k number is K071343.

Other devices from Ellman International, Inc.

Questions

AI-generated answers, 25 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 are the Ellman Noble Alloy Electrodes used for?

    The Ellman Noble Alloy Electrodes are used as electrosurgical accessories with electrosurgical generators, for various surgical procedures.

  • What materials are the electrodes made of?

    The electrodes are fabricated from a noble alloy, which provides durability and effectiveness in surgical procedures.

  • Are the Ellman Noble Alloy Electrodes supplied in different sizes and designs?

    Yes, the electrodes are supplied in various designs and sizes, including loop, needle, ball, fine wire, tapered ball, and VariTip, to accommodate different surgical needs.

  • What is the regulatory status of the Ellman Noble Alloy Electrodes?

    The device has an FDA 510(k) authorization, with a clearance type of traditional, and the k number is K071343, indicating substantial equivalence.