GZKClass II

Electrode, Nasopharyngeal

21 CFR 882.1340 / Neurology

GZK is the FDA product code for Electrode, Nasopharyngeal, a class II device type, regulated under 21 CFR 882.1340. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 2003-08-01, and no recalls.

Classification record

Product code: GZK
Device name: Electrode, Nasopharyngeal
Regulation: 21 CFR 882.1340
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code GZK

By decision year

2 clearances under product code GZK with a decision year between 1983 and 2003, 1983 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code GZK by decision year
Year	Clearances
1983	1
2003	1

Applicants with the most clearances

Product code GZK

Applicants holding the most 510(k) clearances under product code GZK
Applicant	Clearances
Bertone & Assoc.	1
Viasys Healthcare GmbH	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GZK.

Recent clearances

Product code GZK

Recent recalls

Product code GZK

FDA records show no recalls under product code GZK.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)