Ad-Tech Sub Dural Electrodeds

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K923803 ↗

FDA product code

GYC

FDA applicant

Ad-Tech Medical Instrument Corp

Device class

Class II

Regulation

21 CFR Part 882.1310

Advisory committee

Neurology

FDA decision

SESE Substantially Equivalent

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• What are the primary clinical uses for the Ad-Tech Sub Dural Electrodes, and how do they function in neurological monitoring?

  The Ad-Tech Sub Dural Electrodes are designed specifically for intracranial monitoring and recording of brain electrical activity. They are primarily used in neurological applications such as epilepsy assessment and evaluation of brain diseases. These electrodes are implanted beneath the dura mater to capture precise cortical signals, enabling clinicians to analyze seizure activity, brain function, or other neurological conditions in real-time.

• Are the Ad-Tech Sub Dural Electrodes intended for single-use or reusable applications, and what materials are they made from?

  The Ad-Tech Sub Dural Electrodes are supplied sterile and explicitly intended for single-use only. They come in two material configurations: platinum or stainless steel, which are both biocompatible and suitable for intracranial applications. This design ensures patient safety and reduces the risk of infection or contamination.

• What are the key dimensions of the Ad-Tech Sub Dural Electrodes, and how do they differ between models?

  The electrodes feature a standardized contact spacing of 10mm and a width of 8mm, ensuring consistent placement and signal accuracy. While the manufacturer offers platinum and stainless steel options, these dimensions remain uniform across both configurations. The choice between materials may influence clinical preference based on factors like conductivity or durability, but the physical dimensions do not vary.

• How should the Ad-Tech Sub Dural Electrodes be stored, and what precautions should be taken given their sterile, single-use nature?

  Since the electrodes are sterile and intended for single-use, they should be stored in their original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging must remain intact until immediate preoperative use to maintain sterility. Proper storage ensures the electrodes remain uncontaminated and ready for sterile surgical procedures.

• What regulatory pathway does the Ad-Tech Sub Dural Electrodes follow, and how does this affect their availability or use?

  The Ad-Tech Sub Dural Electrodes are classified as Class II medical devices under FDA regulations and have obtained 510(k) clearance (K923803). This clearance confirms they meet FDA standards for safety and effectiveness, ensuring they can be legally marketed and used in the U.S. for their intended neurological monitoring purposes. The regulatory classification also aligns with the Neurology specialty, reinforcing their use in clinical settings for epilepsy and brain disease assessment.