NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230320 FDA 510(k)
- FDA Product Code
- ETN FDA 510(k)
- Models / Variants
- CONTACT Reinforced EMG Endotracheal Tube 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 NIM Standard Reinforced EMG Endotracheal Tube and CONTACT Reinforced EMG Endotracheal Tube are reinforced endotracheal tubes designed for airway management, incorporating electromyographic (EMG) monitoring capabilities. These tubes are intended to support controlled ventilation and verify proper tracheal placement during intubation procedures.
These devices are supplied sterile and intended for single-use. They are regulated under FDA 510(k) clearance (K230320) and classified as Class II medical devices (ETN product code). Due to reported incidents of airway obstruction, these devices have been recalled and should not be used.
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: PDF URGENT: MEDICAL DEVICE RECALL NIM Contact™ EMG Reinforced Endotracheal ..., Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube and the ..., Do Not Use Medtronic NIM Standard and Contact EMG Endotracheal Tubes, PDF URGENT: MEDICAL DEVICESAFTETY NOTICE FOLLOW UP Medtronic NIM ™ Standard ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230320 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA 510(k) K230320 24 fields · synced Oct 5, 2026