Identifiers
- 510(k) Number
- K122040 FDA 510(k)
- FDA Product Code
- ETN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.1820 FDA 510(k)
- Regulation Number
- 874.1820 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Invotec Laryngeal Electrode is a Stimulator, Nerve (OpenFDA classification) designed for electromyographic (EMG) monitoring. It functions as a sensor to continuously assess laryngeal nerve activity during surgical procedures, aiding in the preservation of vocal cord function.
This device is supplied as a sterile, single-use, self-adhesive electrode intended for attachment to an endotracheal tube. It is classified under product code ETN (Ear, Nose, Throat) and has received FDA 510(k) clearance via the Traditional pathway. No additional regulatory markings (e.g., MRI safety, reusable status) are specified in the data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Invotec International, Inc., INVOTEC LARYNGEAL ELECTRODE (K122040) — FDA 510(k) | Innolitics, K122040 FDA 510 (k) - INVOTEC LARYNGEAL ELECTRODE
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122040 | Class II | Active |
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Manufacturer
- Manufacturer
- Invotec International, Inc.
Sources (1)
- FDA 510(k) K122040 24 fields · synced Sep 19, 2026