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Ultrablator Electrode

by Linvatec Corp. 2 variants

510(k) K030720

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 NumberK030720 Date3 Jun 2003ClearedStatusActive

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  • Withdrawn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, 27 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 Ultrablator Electrode is a device used in arthroscopic procedures for knee, shoulder, ankle, wrist and elbow applications. It is designed to provide ablation capabilities during these surgical interventions.

The device is supplied sterile, single-use, and sterilized using Ethylene Oxide. It is substantially equivalent in design, technology and intended use to Linvatec's existing UltrAblator Electrode, with FDA 510(k) clearance under product code GEI.

Other devices from Linvatec Corp.

See all devices from Linvatec Corp. →

Questions

AI-generated answers, 27 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 Ultrablator Electrode used for?

    The Ultrablator Electrode is designed for ablation during arthroscopic procedures in knee, shoulder, ankle, wrist and elbow applications. It provides surgeons with a specialized tool for tissue ablation during these surgical interventions.

  • How is the Ultrablator Electrode supplied and sterilized?

    The device is supplied sterile and is intended for single-use only. It is sterilized using Ethylene Oxide sterilization method to ensure sterility for each procedure.

  • What is the regulatory status of the Ultrablator Electrode?

    The Ultrablator Electrode has FDA 510(k) clearance under product code GEI. It is substantially equivalent in design, technology and intended use to Linvatec's existing UltrAblator Electrode.

  • Is the Ultrablator Electrode reusable?

    No, the Ultrablator Electrode is designed for single-use only. It should not be reused on multiple patients as it is supplied sterile and intended for one-time use to maintain sterility and performance.