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Codetron Transcutaneous Electrical Nerve Stimula.

by Cordis Corp.

510(k) K863469

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK863469 Date20 Feb 1987ClearedStatusActive

Official records

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  • Withdrawn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
GZJ
Device class
Class II
Regulation
21 CFR Part 882.5890
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Codetron Transcutaneous Electrical Nerve Stimulator is a medical device designed for pain relief. It functions by delivering electrical stimulation through the skin to help manage pain symptoms.

This device is classified as a Class II medical device under product code GZJ. It received FDA 510(k) clearance on February 20, 1987, under submission number K863469.

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