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Electrocautery Probe

by Wiltek Medical, Inc.

510(k) K910334

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 NumberK910334 Date21 Feb 1991ClearedStatusActive

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  • Withdrawn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, 23 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 Electrocautery Probe is a device used for cutting or coagulating tissue through the application of electrical current. It is designed to provide precise control during surgical procedures by delivering focused energy to the targeted area.

This device is supplied as a single-use or reusable item depending on the specific model, and is available in various sizes to accommodate different surgical needs. It is intended for use in general and plastic surgery procedures, with storage requirements as specified by the manufacturer. The device has received FDA 510(k) clearance with the product code GEI.

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