Wyler Sphenoidal Electrode
by Ad-Tech Medical Instrument Corp.
510(k) K861031
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861031 | Date25 Aug 1986 | 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- Withdrawn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
- FDA applicant
- Ad-Tech Medical Instrument Corp
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1330
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Wyler Sphenoidal Electrode is a depth electrode designed for intracranial recording and monitoring of electrical activity in the brain. It is classified as an Electrode, Depth (product code GZL) and is used to assess neurological function, particularly in epilepsy and related disorders.
This device is supplied sterile and intended for single-use, though reuse may be possible under controlled conditions. It is regulated under FDA 510(k) clearance (K861031) and falls under Class II – Special Controls. The electrode is intended for use in neurosurgical settings and is compatible with MRI environments as per regulatory standards. Storage and handling must adhere to sterile medical device protocols.
From the manufacturer
Ad-Tech Medical Instrument Corporation The World's Leader As the world leader, Ad-Tech's electrode devices are used in surgical cases for long-term EEG monitoring*, brain mapping, SEEG, and brain stimulation of persons with intractable epilepsy and other brain diseases/disorders. *Long Term Monitoring: Device use is indicated for up to 29 days.
Other devices from Ad-Tech Medical Instrument Corp.
Questions
AI-generated answers, 18 Sep 2026
What clinical specialties primarily use the Wyler Sphenoidal Electrode, and why is it relevant to them?
The Wyler Sphenoidal Electrode is primarily used in neurology, particularly for assessing neurological function in patients with epilepsy and related disorders. Its design allows for intracranial recording of brain electrical activity, which is critical for diagnosing seizure foci, monitoring epilepsy treatment, and guiding surgical interventions like resection or stimulation therapies.
Is this device compatible with MRI environments, and how does that affect its use in clinical settings?
Yes, the Wyler Sphenoidal Electrode is explicitly designed to be compatible with MRI environments, as noted in its regulatory documentation. This compatibility is essential for neurosurgical settings where patients may require both intracranial monitoring and MRI scans for detailed anatomical or functional imaging, such as pre-surgical planning or post-operative evaluation.
How is the Wyler Sphenoidal Electrode supplied, and what are the implications for its reuse?
The device is supplied sterile and intended for single-use, though the manufacturer acknowledges that controlled reuse may be possible under specific conditions. This distinction is important for infection control protocols—single-use ensures sterility for each patient, while controlled reuse could reduce costs but requires strict adherence to reprocessing guidelines to maintain safety and efficacy.
What regulatory pathway does this device follow, and what does that mean for its use in hospitals?
The Wyler Sphenoidal Electrode follows the FDA 510(k) clearance pathway, classified as a Class II device under Special Controls for depth electrodes (product code GZL). This means it has undergone premarket review to demonstrate substantial equivalence to a predicate device, ensuring it meets performance standards for intracranial recording. Hospitals can rely on this clearance to confirm the device’s safety and effectiveness for its intended use in neurosurgical monitoring.