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Disposable Lectroswitch, Model E2503

by Valleylab, Inc. 510(k)

Active United States

510(k) K781510

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781510 Date24 Oct 1978ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 24 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 Disposable Lectroswitch, Model E2503, is an electrosurgical device categorized for cutting and coagulation. It functions as an accessory within electrosurgical systems used in general and plastic surgery.

This device is supplied as a single-use, disposable instrument. It has received FDA 510(k) clearance under the product code GEI and is classified as a Class II medical device.

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Questions

AI-generated answers, 24 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 primary clinical application for the Lectroswitch E2503?

    The Lectroswitch E2503 is an electrosurgical accessory specifically designed to perform cutting and coagulation procedures. It is intended for use within electrosurgical systems during general and plastic surgery operations.

  • Is the Lectroswitch E2503 intended for multiple uses?

    No, this device is supplied as a single-use, disposable instrument. It is designed to be used for one procedure and then discarded to ensure patient safety and maintain the integrity of the electrosurgical system.

  • What is the regulatory status of this device?

    The Lectroswitch E2503 is classified as a Class II medical device and has received FDA 510(k) clearance under the product code GEI, confirming it is substantially equivalent to legally marketed predicate devices.