Depth Electrode
by Ad-Tech Medical Instrument Corp. 2 variants
510(k) K964644
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK964644 | Date9 May 1997 | 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- Withdrawn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 Class II medical device classified under 882.1330 as an electrode used for temporary stimulation of or recording electrical signals at subsurface levels of the brain. It facilitates intracranial monitoring, brain mapping, and stimulation in neurological procedures, particularly for epilepsy and related disorders.
This device is supplied sterile and intended for single-use, as indicated by its FDA 510(k) clearance (K964644) under the Neurology advisory committee. It is designed for use in surgical settings, adhering to MRI safety standards for subsurface brain applications. Sizes and configurations are standardized for intracranial placement, with regulatory compliance ensured under 882.1330 performance standards.
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 types of neurological procedures is the Depth Electrode primarily designed for, and how does it assist in those procedures?
The Depth Electrode is specifically designed for intracranial monitoring, brain mapping, and stimulation during neurological procedures, particularly for epilepsy and related disorders. It facilitates temporary stimulation or recording of electrical signals at subsurface brain levels, enabling precise localization and assessment of neural activity during surgery or diagnostic evaluations.
Is the Depth Electrode reusable or single-use, and what does that mean for its handling and storage?
The Depth Electrode is intended for single-use only, as confirmed by its FDA 510(k) clearance. This means each sterile package should be used for one procedure only, reducing the risk of contamination or cross-infection. Proper storage in a clean, dry environment and adherence to sterile handling protocols are essential to maintain its integrity before use.
What safety considerations should be taken into account when using the Depth Electrode in a surgical setting?
The Depth Electrode adheres to MRI safety standards for subsurface brain applications, ensuring compatibility with magnetic resonance imaging during procedures. Its design is standardized for intracranial placement, and it is classified under 882.1330, which includes performance standards to ensure safe and effective use in neurological surgeries.
How do I verify the regulatory compliance of the Depth Electrode before purchasing or using it?
The Depth Electrode holds FDA 510(k) clearance (K964644) under the Neurology advisory committee, confirming its compliance with U.S. regulatory requirements. The product is also classified under the product code GZL and regulation number 882.1330, which categorizes it as an electrode for subsurface brain stimulation or recording. Always verify the registration numbers and clearance details with the manufacturer or regulatory databases to ensure authenticity.