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Model I 100 Rf Passive Attenuator/Splitter And Model Ql 10 Loop Electrode

by Quantum Loop, Inc.

510(k) K964779

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 NumberK964779 Date27 Aug 1997ClearedStatusActive

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  • Withdrawn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
Models / Variants
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 Model I 100 Rf Passive Attenuator/Splitter And Model Ql 10 Loop Electrode is an electrosurgical device, classified as a cutting and coagulation device. It is used for the cutting and coagulation of tissue. The device consists of a passive attenuator/splitter and a loop electrode.

The device is supplied with a product code of GEI and is classified as a Class II device with special controls. It has been cleared by the FDA with a 510(k) number of K964779, with a decision of Substantially Equivalent. The device is intended for use by qualified medical personnel in electrosurgery.

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 Model I 100 RF Attenuator/Splitter and QL 10 Loop Electrode used for?

    The device is used for the cutting and coagulation of tissue in electrosurgery by qualified medical personnel.

  • How is the device supplied?

    The device is supplied with a product code of GEI and is classified as a Class II device with special controls.

  • Is the device cleared by the FDA?

    Yes, the device has been cleared by the FDA with a 510(k) number of K964779, with a decision of Substantially Equivalent.

  • What type of medical personnel can use the device?

    The device is intended for use by qualified medical personnel in electrosurgery, including those in general and plastic surgery.