Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes

Q: What is the product code of K053358?

The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.

FDA 510(k) K053358 · Ad-Tech Medical Instrument Corp

Substantially Equivalent

510(k) numberK053358

Submission

Device name: Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes
Applicant: Ad-Tech Medical Instrument Corp
Stoughton, WI, US
Received: December 2, 2005
Decision date: May 25, 2006
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GZL – Electrode, Depth
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1330
Specialty: Neurology

Other 510(k)s with product code GZL

510(k)	Device	Applicant	Decision
K253970	Wovyn Depth ElectrodeGZL · Traditional	Sensomedical Labs, Ltd.	04/17/2026SE
K250363	Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…GZL · Traditional	Beijing Sinovation Medical Technology Co., Ltd.	11/05/2025SE
K250601	Neuro Omega System; NeuroSmart SystemGZL · Special	Alpha Omega Engineering , Ltd.	03/30/2025SE
K223276	Anchor Bolts as Accessories to Depth ElectrodesGZL · Traditional	Ad-Tech Medical Instrument Corporation	05/18/2023SE
K223269	Spencer Probe Depth ElectrodesGZL · Traditional	Ad-Tech Medical Instrument Corporation	05/18/2023SE
K213170	SENSOSEEG Depth ElectrodesGZL · Traditional	Sensomedical Labs, Ltd.	04/18/2023SE
K222706	iCE-SG2 Subcutaneous Electrode KitGZL · Traditional	Ice Neurosystems, Inc.	12/06/2022SE
K222404	Evo® sEEG SystemGZL · Traditional	Neuroone Medical Technologies Corp.	10/20/2022SE
K220553	Neuro Omega System, NeuroSmart SystemGZL · Special	Alpha Omega Engineering , Ltd.	09/16/2022SE
K202087	DIXI Medical Microdeep Micro-Macro Depth ElectrodesGZL · Traditional	Dixi Medical	11/18/2021SE

More from Dixi Medical

510(k)	Device	Decision
K223276	Anchor Bolts as Accessories to Depth ElectrodesGZL · Traditional	05/18/2023SE
K223269	Spencer Probe Depth ElectrodesGZL · Traditional	05/18/2023SE
K191186	Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid…GYC · Traditional	01/25/2020SE
K181544	Anchor Bolt (as an accessory to Depth Electrodes)GZL · Traditional	08/09/2018SE
K170442	Cranial Drill Bits and AccessoriesHBE · Traditional	09/07/2017SE
K163355	Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…GZL · Traditional	04/12/2017SE
K152769	Fremap ElectrodeETN · Traditional	05/06/2016SE
K152547	DNAP ElectrodeGZL · Traditional	03/04/2016SE
K112094	Brain Biopsy NeedleHAW · Traditional	04/24/2012SE
K053363	Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes…GYC · Abbreviated	05/30/2006SE

Questions and answers

When was Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes cleared by the FDA?

Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes (K053358) received a 510(k) decision of Substantially Equivalent on May 25, 2006, 174 days after the submission was received.

What is the product code of K053358?

The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.