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Sheath, Electrosurgical Pencil

by Aspen Laboratories, Inc. 510(k)

Active United States

510(k) K963088

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963088 Date13 Sep 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-1757-2017 FDA Class II initiated 28 Feb 2017
    • Terminated Z-1758-2017 FDA Class II initiated 28 Feb 2017
    • Terminated Z-1759-2017 FDA Class II initiated 28 Feb 2017
    • Terminated Z-1756-2017 FDA Class II initiated 28 Feb 2017
    • Terminated Z-1760-2017 FDA Class II initiated 28 Feb 2017

    For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.

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, 22 Sep 2026

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

A sheath, electrosurgical pencil is a device used in conjunction with electrosurgery pencils to provide a protective covering for the handpiece and cord during surgical procedures. It is designed to reduce the need for continuous sterilization by offering a disposable barrier between the electrosurgical pencil and the surgical field.

The device is supplied as a disposable, non-sterile or sterile handpiece sheath, available in lengths such as 38 inches, and is packaged in quantities of 25 or 100 per box. It is intended for use in general and plastic surgery settings, and its regulatory status is based on FDA 510(k) clearance K963088, which was granted as substantially equivalent to a predicate device.

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