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Loop Electrode, Ball Electrode

by Palm Medical USA, Inc.

510(k) K993527

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 NumberK993527 Date6 Jul 2000ClearedStatusActive

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  • Withdrawn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, 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.

The Loop Electrode and Ball Electrode are gynecologic electrocautery devices and accessories. These instruments are designed for use in loop and LLETZ procedures.

This device is regulated as a Class II medical device under 21 CFR 884.4120. It received FDA 510(k) clearance on July 6, 2000, under submission number K993527.

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 are the Loop and Ball Electrodes used for?

    These instruments are specialized gynecologic electrocautery devices designed to be used during loop and LLETZ (Loop Electrosurgical Excision Procedure) procedures.

  • What is the regulatory status of these devices?

    These devices are regulated as Class II medical devices under 21 CFR 884.4120. They received FDA 510(k) clearance on July 6, 2000, under submission number K993527.

  • Who is the manufacturer of these electrocautery devices?

    The Loop and Ball Electrodes are manufactured by Palm Medical USA, Inc., located in Gainesville, Florida.