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Electrosurgical Pencil with Electrode WP200

by Wickimed Supply Limited

510(k) K100258

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 · Abbreviated NumberK100258 Date28 Apr 2010ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

An electrosurgical pencil with electrode is a handheld accessory for high voltage high frequency electrosurgical devices. It operates under a frequency range of 0.2 - 5 MHz with a maximum peak-to-peak voltage level of 9000V.

The device is supplied as a non-sterile, reusable accessory intended for use in general and plastic surgery settings. It is authorized under FDA 510(k) clearance K100258 and is substantially equivalent to a predicate device.

Questions

AI-generated answers, 21 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 ELECTROSURGICAL PENCIL WITH ELECTRODE WP200 used for?

    The ELECTROSURGICAL PENCIL WITH ELECTRODE WP200 is a handheld accessory designed for use with high voltage, high frequency electrosurgical devices in general and plastic surgery settings. It delivers controlled electrical energy for cutting or coagulating tissue during procedures, operating within a frequency range of 0.2 to 5 MHz and a maximum peak-to-peak voltage of 9000V.

  • Is the ELECTROSURGICAL PENCIL WITH ELECTRODE WP200 sterile or non-sterile, and is it intended for single use or reuse?

    The device is supplied as a non-sterile accessory and is intended for reuse. It must be cleaned and sterilized by the user before each use according to established reprocessing protocols for reusable surgical instruments, as it is not provided in a sterile condition.

  • What are the key electrical specifications of the ELECTROSURGICAL PENCIL WITH ELECTRODE WP200?

    The WP200 model operates within a frequency range of 0.2 to 5 MHz and can withstand a maximum peak-to-peak voltage level of 9000V. These specifications define its compatibility with high-frequency electrosurgical generators and ensure safe delivery of energy during surgical applications.

  • How is the ELECTROSURGICAL PENCIL WITH ELECTRODE WP200 supplied and what regulatory pathway was used for its authorization?

    The device is supplied as a non-sterile, reusable accessory. It received authorization through the FDA 510(k) pathway under clearance number K100258, demonstrating substantial equivalence to a predicate device. This regulatory route confirms its safety and effectiveness for the intended use in general and plastic surgery.