Identifiers
- 510(k) Number
- K110422 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)
Surgical stimulators are nerve stimulator devices designed for tissue dissection and the stimulation of cranial and peripheral motor nerves. They are used during surgical procedures to assist in the location and identification of nerves, including spinal nerve roots.
These devices are supplied by Technomed Europe and have received FDA 510(k) clearance. The stimulators are intended for use in clinical settings to provide feedback regarding nerve proximity during surgery.
Frequently asked questions
What are surgical stimulators used for?
These devices are designed to assist surgeons during procedures by stimulating cranial and peripheral motor nerves. They help in the location and identification of nerves, including spinal nerve roots, and provide feedback regarding nerve proximity during tissue dissection.
Who manufactures these nerve stimulators?
These surgical stimulators are supplied by Technomed Europe, based in Maastricht-Airport, Netherlands.
What is the regulatory status of these devices?
These devices have received FDA 510(k) clearance under the regulation number 874.1820, which classifies them as nerve stimulators for clinical use.
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: SURGICAL STIMULATORS (K110422) — FDA 510(k) | Innolitics, Neuromonitoring - Technomed, Technomed Europe FDA 510(k) Neurology Products - Latest 2026, Neuromuscular stimulation electrode - TE/Q95-931 - Technomed Europe
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110422 | Class II | Active |
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Manufacturer
- Manufacturer
- Technomed Europe
Sources (1)
- FDA 510(k) K110422 24 fields · synced Sep 25, 2026