Cleared Traditional

RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES

K022914 · Rhythmlink International, LLC · Neurology
Dec 2002
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K022914 is an FDA 510(k) clearance for the RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES, a Electrode, Needle (Class II — Special Controls, product code GXZ), submitted by Rhythmlink International, LLC (Cayce, US). The FDA issued a Cleared decision on December 20, 2002, 108 days after receiving the submission on September 3, 2002. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1350.

Submission Details

510(k) Number K022914 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2002
Decision Date December 20, 2002
Days to Decision 108 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXZ — Electrode, Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1350

Similar Devices — GXZ Electrode, Needle

All 52
Disposable Subdermal Needle Electrode, Corkscrew
K241045 · Technomed Europe · Dec 2024
Medical Disposable Sterile Needle Electrode
K232581 · Suzhou Haishen Medical Device Associates Co., Ltd. · Dec 2023
Phantom XL Insulated Dilators
K231691 · TeDan Surgical Innovations, Inc. · Jun 2023
Guardian Needle Electrode
K200984 · Rhythmlink International, LLC · May 2020
Spes Medica Subdermal Needle Electrodes
K192603 · Spes Medica Srl · Nov 2019
PressOn Electrode Headset
K190801 · Rhythmlink International, LLC · Jul 2019