Spencer Probe Depth Electrodes
by Ad-Tech Medical Instrument Corporation
510(k) K223269
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223269 | Date18 May 2023 | 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- Withdrawn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
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1330
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Spencer Probe Depth Electrodes are Depth Electrodes designed for neurological monitoring and recording, as classified under the nomenclature for electrophysiological devices. These electrodes are intended for intracranial depth recording, enabling precise measurement of electrical activity within the brain tissue for diagnostic and research purposes in neurology.
These electrodes are supplied as single-use, sterile devices with a 1.1 mm diameter and include an optional stay flange for strain relief. They feature 5 mm or 10 mm contact spacing and are regulated under FDA 510K clearance (K223269) as substantially equivalent to a predicate device. The product is intended for use in clinical settings requiring high-density depth electrode placement, adhering to Class II medical device standards (882.1330).
From the manufacturer
Spencer Probe Depth Electrodes Spencer Probe depth electrodes have the following features: 1.1mm diameter Includes stay flange for strain relief 5mm or 10mm contact spacing High Density Depth Electrodes Smaller contacts with tight spacing options sEEG Depth Electrodes Reduced diameter design for less invasive depth electrode placement.
Other devices from Ad-Tech Medical Instrument Corp.
Questions
AI-generated answers, 19 Sep 2026
What clinical specialties primarily use the Spencer Probe Depth Electrodes, and why are they designed for this purpose?
The Spencer Probe Depth Electrodes are primarily used in neurology for intracranial depth recording. They are designed to measure electrical activity within brain tissue with high precision, enabling diagnostic and research applications such as epilepsy monitoring, brain mapping, or neurosurgical planning. Their specialized construction allows for targeted placement deep within the brain, which is critical for conditions requiring detailed neural signal analysis.
Are these electrodes intended for single-use or reusable applications, and what does that mean for clinical workflows?
The Spencer Probe Depth Electrodes are single-use, sterile devices, meaning each electrode is intended for one patient procedure only. This design reduces infection risk and eliminates the need for reprocessing, streamlining workflows in operating rooms or neurophysiology labs. Clinicians should follow standard single-use protocols, including proper disposal after use.
What are the available sizes and contact spacing options for these electrodes, and how might that affect patient selection?
The Spencer Probe Depth Electrodes come in two contact spacing configurations: 5 mm and 10 mm. The 5 mm spacing offers finer granularity for localized brain activity recording, ideal for high-resolution studies or smaller target areas, while the 10 mm spacing may be preferred for broader coverage or less dense electrode placement. The 1.1 mm diameter remains consistent across models, ensuring compatibility with standard intracranial insertion tools.
Do these electrodes include any additional features to improve safety or usability during insertion?
Yes, the Spencer Probe Depth Electrodes feature an optional stay flange designed for strain relief. This component helps secure the electrode during insertion and reduces the risk of accidental dislodgment or damage to the electrode shaft, which could compromise signal integrity or patient safety. The flange is particularly useful in procedures requiring precise, stable electrode placement.
How should these electrodes be stored to maintain their sterility and performance before use?
Since these are sterile, single-use devices, they should be stored in their original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging is designed to preserve sterility, so it should remain intact until immediately before use. Clinicians should check for any visible damage to the packaging before opening, as compromised seals could compromise sterility.