SENSOSEEG Depth Electrodes
510(k) K213170
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213170 | Date18 Apr 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- Withdrawn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, 1 Oct 2026
The SENSOSEEG Depth Electrodes are depth electrodes designed for neurological monitoring and recording. These devices are classified under the nomenclature for depth electrodes (21 CFR 882.1330) and are intended for invasive electrophysiological studies, such as electrocorticography (ECoG) or depth EEG, to assess brain activity in clinical settings. They provide precise localization of epileptic foci or other neurological signals by penetrating deep brain structures.
These electrodes are supplied sterile and intended for single-use, adhering to Class II regulatory standards under product code GZL. They are used in operating rooms, neurophysiology labs, or intensive care units for procedures requiring high-resolution brain signal acquisition. The devices are cleared by the FDA through a 510(k) submission (K213170) under the Traditional pathway, with no third-party involvement. Storage and handling must comply with sterile medical device protocols to ensure integrity before use.
Other devices from Sensomedical Labs, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What are the SENSOSEEG Depth Electrodes used for?
The SENSOSEEG Depth Electrodes are designed for invasive electrophysiological studies, such as electrocorticography (ECoG) or depth EEG. They enable precise localization of epileptic foci or other neurological signals by penetrating deep brain structures, making them ideal for high-resolution brain activity assessment in clinical settings like operating rooms, neurophysiology labs, or intensive care units.
Are the SENSOSEEG Depth Electrodes sterile and single-use?
Yes, the SENSOSEEG Depth Electrodes are supplied sterile and intended for single-use only. This ensures patient safety and maintains device integrity, adhering to sterile medical device protocols before use.
How should the SENSOSEEG Depth Electrodes be stored?
The SENSOSEEG Depth Electrodes must be stored and handled according to sterile medical device protocols to preserve their integrity. Proper storage conditions are critical to ensure the electrodes remain uncontaminated and ready for use in clinical procedures.
What regulatory pathway was used for FDA clearance of these electrodes?
The SENSOSEEG Depth Electrodes were cleared by the FDA through a 510(k) submission (K213170) under the Traditional pathway. This pathway confirms that the device is substantially equivalent to a predicate device already on the market, ensuring compliance with Class II regulatory standards.
What product code and classification apply to the SENSOSEEG Depth Electrodes?
The SENSOSEEG Depth Electrodes are classified under product code GZL and fall under the Class II regulatory category (21 CFR 882.1330). This classification reflects their use in invasive electrophysiological procedures and the associated risk management requirements.