Depth Electrode
by Ad-Tech Medical Instrument Corp. 2 variants
510(k) K891920
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK891920 | Date27 Jul 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Ad-Tech's Depth Electrode
- 510(k) Number
- FDA product code
- GZL
- FDA applicant
- Ad-Tech Medical Instrument Corp
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1330
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Depth Electrode is a medical device classified as an Electrode, Depth under FDA nomenclature, designed for intracranial recording and monitoring of electrical activity within the brain. It facilitates precise localization of epileptic foci and other neurological signals by positioning electrodes at specific depths, enabling detailed brain mapping and seizure monitoring during both intraoperative and long-term studies.
This device is supplied sterile and intended for single-use, adhering to FDA’s 510(k) clearance (K891920) under the GZL product code for Class II Neurology applications. It is intended for use in MRI-safe environments and must be handled and stored according to manufacturer guidelines to maintain sterility. The device is regulated under 21 CFR 882.1330 and is not reusable.
From the manufacturer
Ad-Tech Medical Instrument Corporation The World's Leader As the world leader, Ad-Tech's electrode devices are used in surgical cases for long-term EEG monitoring*, brain mapping, SEEG, and brain stimulation of persons with intractable epilepsy and other brain diseases/disorders. *Long Term Monitoring: Device use is indicated for up to 29 days.
Ad-Tech Medical offers high-performance depth electrodes for sEEG diagnostics, subsurface brain mapping, and epilepsy monitoring.
Other devices from Ad-Tech Medical Instrument Corp.
Questions
AI-generated answers, 18 Sep 2026
What is the primary clinical purpose of the Depth Electrode, and how does it differ from surface electrodes in brain monitoring?
The Depth Electrode is specifically designed for intracranial recording to monitor electrical activity within the brain at precise depths. Unlike surface electrodes, which only capture signals from the brain’s outer layers, this device allows for detailed localization of epileptic foci and other neurological signals by positioning electrodes at targeted depths. This enables accurate brain mapping and seizure monitoring during both intraoperative procedures and long-term studies, making it ideal for complex neurological assessments.
Is the Depth Electrode reusable, and if not, what are the implications for clinical workflows?
No, the Depth Electrode is intended for single-use only and is supplied sterile. This design ensures patient safety by eliminating the risk of cross-contamination between uses. Clinicians must adhere to manufacturer guidelines for handling and storage to maintain sterility, which may require additional planning for inventory and disposal in clinical workflows.
Can this device be used in MRI environments, and what precautions should be taken during its use?
Yes, the Depth Electrode is designed for use in MRI-safe environments. However, it must be handled and stored according to the manufacturer’s guidelines to preserve its MRI compatibility and sterility. Clinicians should confirm compatibility with their specific MRI system and follow all safety protocols to avoid interference or damage to the device.
What regulatory pathway was followed for this device, and how does that affect its use in clinical settings?
The Depth Electrode received FDA clearance through a 510(k) submission (K891920) under the GZL product code, classified as a Class II device under 21 CFR 882.1330. This clearance indicates it meets FDA standards for safety and effectiveness in neurology applications, specifically for intracranial recording and monitoring. Clinicians can rely on this regulatory status to ensure the device adheres to established medical device guidelines for use in neurological procedures.