Macro-Micro Depth Electrode
by Ad-Tech Medical Instrument Corp.
510(k) K041604
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041604 | Date16 Aug 2004 | 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- Withdrawn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
- 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 Macro-Micro Depth Electrode is a depth electrode used for intracranial recording and stimulation in neurological procedures. It facilitates precise monitoring of brain activity, particularly in epilepsy and other neurological disorders, by providing detailed depth recordings from specific brain regions.
This device is intended for single-use and is supplied sterile. It is classified as a Class II medical device under FDA regulations (21 CFR 882.1330) and has received FDA 510(k) clearance (K041604) for substantial equivalence. The electrode is designed for use in surgical settings, where it is implanted to enable long-term EEG monitoring and brain mapping, typically for up to 29 days.
From the manufacturer
The AD-TECH® Disposable Drill Kits are an optional accessory to Macro-Micro Depth Electrodes. When used with a compatible Surgical Drill, the Drill Kit makes a burr hole to accept the Anchor Bolt or Depth Electrode.
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.
Other devices from Ad-Tech Medical Instrument Corp.
Questions
AI-generated answers, 18 Sep 2026
What is the primary clinical use of the Macro-Micro Depth Electrode in neurological procedures?
The Macro-Micro Depth Electrode is designed for intracranial recording and stimulation during neurological procedures, particularly for epilepsy and other neurological disorders. It enables precise monitoring of brain activity by providing detailed depth recordings from specific brain regions, which is critical for long-term EEG monitoring and brain mapping.
Is the Macro-Micro Depth Electrode intended for single-use or reusable applications?
The device is explicitly intended for single-use only, as stated in its specifications. This ensures sterility and reduces the risk of cross-contamination in surgical settings.
How long can the Macro-Micro Depth Electrode typically remain implanted for monitoring?
The electrode is designed for long-term implantation, with typical use durations of up to 29 days for continuous intracranial recording and stimulation in neurological procedures.
What regulatory pathway was followed for FDA clearance of this device?
The Macro-Micro Depth Electrode received FDA 510(k) clearance (K041604) under an Abbreviated pathway, demonstrating substantial equivalence to a predicate device. The submission was reviewed by the Neurology (NE) Advisory Committee and classified as a Class II medical device under 21 CFR 882.1330.
How is the Macro-Micro Depth Electrode supplied, and what does this imply for handling?
The device is supplied sterile and intended for single-use, meaning it should be handled as a sterile instrument in surgical settings. This ensures patient safety and compliance with aseptic protocols during implantation.