BRAINSTREAM Disposable Deep Cup EEG Electrodes
510(k) K200540
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200540 | Date1 Jun 2020 | 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- Withdrawn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
- GXY
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1320
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Brainstream Disposable Deep Cup EEG Electrodes are classified as disposable electroencephalography (EEG) electrodes designed for scalp attachment. These deep cup electrodes feature a 10mm diameter cup with a 3mm height, providing stable contact for high-quality signal acquisition during EEG monitoring. Constructed with silver/silver chloride sensors, they ensure consistent signal performance while minimizing interference. Their design supports both CT and X-ray compatibility, making them suitable for multi-modal imaging environments.
These electrodes are supplied in single-patient packaging and are intended for one-time use, eliminating the need for reprocessing. Each electrode includes pre-attached, tangle-free lead wires and a positioning guide for precise placement. The 2mm escape hole allows gel to drain during application and accommodates blunt needle insertion. As a Class II medical device, they are cleared under FDA 510(k) with the product code GXY, adhering to regulatory standards for disposable EEG electrodes.
Other devices from Conmed Corporation
Questions
AI-generated answers, 20 Sep 2026
Are these electrodes reusable or meant for single-use, and how does that affect their setup process?
These electrodes are designed for single-use only, eliminating the need for cleaning, sterilization, or reprocessing between patients. This simplifies setup since each electrode comes in single-patient packaging with pre-attached, tangle-free lead wires and a positioning guide. The disposable nature also reduces the risk of cross-contamination and ensures consistent performance without maintenance.
What makes these EEG electrodes suitable for use alongside CT or X-ray imaging?
The electrodes are explicitly designed with CT and X-ray compatibility in mind, meaning they won’t interfere with imaging modalities that require clear visualization of the scalp or skull. This makes them ideal for multi-modal environments where EEG monitoring is combined with radiologic imaging.
How do the electrode cups ensure stable signal acquisition during EEG monitoring?
The electrodes feature a 10mm diameter cup with a 3mm height, providing a larger contact surface area for stable attachment to the scalp. Combined with silver/silver chloride sensors, they deliver consistent signal performance while minimizing interference. The design also includes a 2mm escape hole to allow gel drainage during application, further enhancing signal clarity.
What storage or handling considerations should be kept in mind for these electrodes?
Since they are disposable and single-patient, storage should follow standard sterile medical device protocols. The packaging should remain intact until use to preserve sterility. After opening, electrodes should be used immediately to avoid exposure to contaminants. The tangle-free lead wires and positioning guide simplify handling, but care should be taken to avoid bending or damaging the wires before application.