NeuroPort Electrode
by Cyberkinetics Neurotechnology Systems, Inc. 510(k)
Active
510(k) K070272
Overview
The NeuroPort Electrode is a Depth Electrode, Microelectrode Array (per FDA classification GZL) designed for intracranial implantation. It records and monitors brain electrical activity, specifically local field potentials, via a silicon-based array featuring 100 electrode contacts arranged in a 4 mm × 4 mm footprint. This device is intended for temporary use in neurosurgical applications, typically for up to 30 days, to facilitate electrophysiological studies or monitoring in the brain cortex.
The device is supplied sterile and intended for single-use implantation. It is regulated under 21 CFR 882.1330 and classified as a Class II medical device, with FDA clearance via a 510(k) submission (K070272). The NeuroPort Electrode requires sterile handling and specialized neurosurgical implantation techniques. No MRI safety information is specified, and storage conditions are not detailed in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070272 | Date3 Aug 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Questions
What is the NeuroPort Electrode designed for?
The NeuroPort Electrode is a depth electrode array intended for intracranial implantation to record and monitor brain electrical activity, specifically local field potentials. It is primarily used in neurosurgical applications for electrophysiological studies or monitoring in the brain cortex, typically for temporary use up to 30 days.
How is the NeuroPort Electrode supplied and intended for use?
The NeuroPort Electrode is supplied sterile and is intended for single-use implantation only. This ensures safety and compliance with sterile handling protocols required for neurosurgical procedures.
What are the key specifications of the NeuroPort Electrode?
The NeuroPort Electrode features a silicon-based microelectrode array with 100 electrode contacts arranged in a 4 mm × 4 mm footprint. It is classified under FDA product code GZL as a depth electrode and is regulated under 21 CFR 882.1330.
Is the NeuroPort Electrode reusable or single-use?
The NeuroPort Electrode is explicitly designed for single-use implantation. Its sterile packaging and temporary use duration (up to 30 days) align with single-use medical device standards to prevent contamination and ensure patient safety.
What storage or handling considerations apply to the NeuroPort Electrode?
While specific storage conditions are not detailed in the regulatory data, the NeuroPort Electrode requires sterile handling due to its single-use nature. It must be stored and prepared according to standard sterile neurosurgical protocols to maintain integrity before implantation.