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Laryngeal Surface Electrode

FDA 510(k)

Class II (US FDA 510(k))

510(k) K093373

by Spes Medica Srl

Identifiers

510(k) Number
K093373 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 Laryngeal Surface Electrode is a nerve stimulator designed for intraoperative monitoring of the recurrent laryngeal nerve. It facilitates electromyographic (EMG) assessment during surgical procedures, particularly in ear, nose, and throat (ENT) applications, to ensure nerve integrity and functionality.

This device is supplied as a single-use, non-sterile electrode integrated into or applied to an endotracheal tube. It is intended for use in MRI-safe environments and is available in standard and armored versions for ease of insertion. The electrode is classified as a Class 2 medical device under FDA regulations and holds a 510(k) clearance (K093373) for substantial equivalence. Sterilization instructions and regulatory compliance are detailed in the accompanying documentation.

Frequently asked questions

What is the primary clinical purpose of the Laryngeal Surface Electrode during surgery?

The Laryngeal Surface Electrode is designed for intraoperative monitoring of the recurrent laryngeal nerve. It enables electromyographic (EMG) assessment during ENT procedures to verify nerve integrity and functionality, ensuring the nerve remains intact during surgery.

Is the Laryngeal Surface Electrode intended for reuse, or is it single-use only?

The device is explicitly labeled as single-use, meaning it is intended for one-time use only and should not be reused after a single application. This is standard practice for maintaining sterility and patient safety.

What types of environments is this electrode compatible with, and how is it integrated into use?

The electrode is designed for MRI-safe environments and is integrated into or applied to an endotracheal tube. It comes in two versions—standard and armored—to facilitate easier insertion during surgical procedures.

How should the Laryngeal Surface Electrode be stored, and what are the sterility considerations?

The electrode is supplied in a non-sterile state, so it must be sterilized prior to use as per the manufacturer’s instructions. Storage conditions and sterilization protocols are detailed in the accompanying documentation to ensure proper handling and safety.

What regulatory pathway was followed for this device, and which medical specialty is it primarily associated with?

The Laryngeal Surface Electrode was cleared through the FDA’s 510(k) pathway, specifically under the Ear, Nose, and Throat (ENT) advisory committee. It is classified as a Class 2 medical device and holds a clearance number (K093373) for substantial equivalence.

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: Laryngeal Electrodes - Spes Medica, Laryngeal Surface Electrode - Spes Medica Srl | FDA Evidence Review, Home - Spes Medica

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spes Medica Srl

Sources (1)

  • FDA 510(k) K093373 24 fields · synced Sep 19, 2026