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Electrosurgical Loop Electrode

by National Wire & Stamping, Inc.

510(k) K940191

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK940191 Date30 Dec 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
HGI
Device Class
Class II
Regulation
21 CFR Part 884.4120
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Electrosurgical Loop Electrode is a device classified under Electrocautery, Gynecologic (and Accessories). It is designed for precise tissue excision, coagulation, or fulguration during surgical procedures, utilizing high-frequency electrical current to cut or seal tissue while minimizing blood loss.

This device is intended for single-use in controlled surgical environments, such as obstetrics and gynecology. It is supplied sterile and must be handled in accordance with standard electrosurgical safety protocols. The device is regulated under FDA 510(k) clearance (K940191) and falls under Device Class II (HGI) as per regulation 884.4120. No MRI safety information is specified.

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