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ESU Handswitching Pencil

by Surgex, Inc.

510(k) K001442

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 NumberK001442 Date31 May 2001ClearedStatusActive

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  • Withdrawn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, 26 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 ESU Handswitching Pencil is an electrosurgical unit (ESU) handswitching pencil used for electrosurgical procedures. It is designed to allow surgeons to control the activation of electrosurgical energy during surgical procedures.

The device is supplied by Surgex, Inc. and is authorized under FDA 510(k) clearance with product code GEI. It is intended for use in general and plastic surgery settings. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

Questions

AI-generated answers, 26 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 ESU Handswitching Pencil used for?

    The ESU Handswitching Pencil is designed for electrosurgical procedures, allowing surgeons to control the activation of electrosurgical energy during surgical operations in general and plastic surgery settings.

  • Is the ESU Handswitching Pencil single-use or reusable?

    The device is not specified as single-use or reusable in the provided information. Users should consult the manufacturer's instructions for specific guidance on usage and disposal.

  • What regulatory approvals does the ESU Handswitching Pencil have?

    The ESU Handswitching Pencil is authorized under FDA 510(k) clearance with product code GEI. It received a decision code of SESE (Substantially Equivalent) on May 31, 2001.

  • What information is available about the ESU Handswitching Pencil's sterility and storage?

    No information regarding sterility, MRI safety, or storage conditions is provided in the device data. Users should refer to the manufacturer's instructions for specific handling and storage requirements.