Wyler Subdural Strip Electrode
by Ad-Tech Medical Instrument Corp.
510(k) K850342
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK850342 | Date30 Jul 1985 | StatusActive |
Official records
- FDA 510(k) database K850342
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- 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
- SN
Overview
AI-generated summary, 18 Sep 2026
The Wyler Subdural Strip Electrode is a Cortical Electrode designed for intracranial electroencephalography (iEEG) monitoring. It is intended for recording electrical activity from the brain’s subdural space, aiding in the diagnosis and management of epilepsy and other neurological conditions by providing continuous, high-resolution data on brain function.
This device is supplied sterile and intended for single-use, featuring platinum or stainless steel construction with contacts spaced 10mm apart on an 8mm-wide strip. It is regulated under FDA 510(k) clearance (K850342) and falls under Class II medical device classification (GYC). Usage is restricted to clinical settings, such as operating rooms or intensive care units, where intracranial monitoring is required.
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.