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Gdc Patient Return Electtrode Model 45021

by Target Therapeutics

510(k) K963307

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 NumberK963307 Date17 Dec 1996ClearedStatusActive

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  • Withdrawn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
HCG
Device Class
Class II
Regulation
21 CFR Part 882.5950
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Gdc Patient Return Electtrode Model 45021 is a patient return electrode indicated for use only with Target Therapeutics Gdc System as the patient return electrode. It is classified as a neurovascular embolization device under FDA device class 2.

The device received FDA 510(k) clearance (K963307) on December 17, 1996, following a traditional review process. It is supplied non-sterile and intended for single-use application in neurology settings, with no MRI safety information provided in the data.

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Questions

AI-generated answers, 25 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 GDC Patient Return Electtrode Model 45021 used for?

    It is indicated for use only as the patient return electrode with the Target Therapeutics Gdc System, which is a neurovascular embolization device, and is intended for use in neurology settings.

  • Is the GDC Patient Return Electtrode Model 45021 sterile or non-sterile, and is it reusable?

    The device is supplied non-sterile and is intended for single-use application only, meaning it should not be reused after initial use.

  • What regulatory pathway was used for the GDC Patient Return Electtrode Model 45021?

    The device received FDA 510(k) clearance (K963307) on December 17, 1996, following a traditional review process and was found substantially equivalent to a predicate device.