Cueva Cranial Nerve Electrode
by Ad-Tech Medical Instrument Corp.
510(k) K944061
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK944061 | Date20 Jan 1995 | StatusActive |
Official records
- FDA 510(k) database K944061
Recalls
-
- Terminated Z-0106-2015
The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .
Timeline
- Cleared FDA 510(k) K944061
- Recall initiated FDA recalls Z-0106-2015
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- Withdrawn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 Cueva Cranial Nerve Electrode is a depth electrode designed for temporary stimulation or recording of electrical signals from subsurface cranial nerve pathways. Classified as an Electrode, Depth, it is intended for use in neurological assessments and monitoring within the cranial nerve system.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K944061) with a classification of Class II (GZL product code) and falls under regulation 882.1330. The electrode is intended for use in neurology settings and has received a Substantially Equivalent (SESE) determination by the Neurology (NE) Advisory Committee.