GZEClass III

Implanted Diaphragmatic/Phrenic Nerve Stimulator

21 CFR 882.5830 / Neurology

GZE is the FDA product code for Implanted Diaphragmatic/Phrenic Nerve Stimulator, a class III device type, regulated under 21 CFR 882.5830. FDA's definition for this code reads: "Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: GZE
Device name: Implanted Diaphragmatic/Phrenic Nerve Stimulator
FDA definition: Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86
Regulation: 21 CFR 882.5830
Device class: Class III
Review panel: Neurology
Submission type: PMA
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Avery Biomedical Devices, Inc.

Recent clearances

Product code GZE

FDA records hold no clearances under product code GZE.

Recent recalls

Product code GZE

FDA records show no recalls under product code GZE.

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)