AD-Tech Epidural Peg Electrode
by Ad-Tech Medical Instrument Corp.
510(k) K912760
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK912760 | Date15 Jan 1992 | 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- Withdrawn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
- 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
Overview
AI-generated summary, 18 Sep 2026
The AD-Tech Epidural Peg Electrode is a Cortical Electrode designed for neurological monitoring and recording. It facilitates the acquisition of electrical activity from the brain’s surface or epidural space, aiding in the diagnosis and management of epilepsy and other neurological conditions through continuous or long-term electrophysiological assessment.
This device is intended for single-use in sterile surgical settings and is classified as a Class II medical device under FDA regulations (21 CFR 882.1310). Supplied as a reusable or disposable electrode (depending on model), it requires proper handling and storage per manufacturer instructions. The electrode is approved under FDA 510(k) clearance (K912760) and adheres to neurological specialty standards, with no specific MRI safety restrictions noted in the data.
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.