Tenax Laser Resistant Endotracheal Tube
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200761 FDA 510(k)
- FDA Product Code
- BTR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5730 FDA 510(k)
- Regulation Number
- 868.5730 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Tenax Laser Resistant Endotracheal Tube is a medical device designed for use in airway surgery, providing protection against surgical fires during laser surgery of the head and neck. It features a smooth outer sheath and laser-resistant design, available in 6 sizes, all with a stylet. The device is intended to reduce vocal cord damage and provide maximum safety during procedures.
The Tenax Laser Resistant Endotracheal Tube is supplied in various sizes and is designed for single-use. It is regulated under the product code BTR and has a regulation number of 868.5730. The device has been authorized by the FDA under the 510K clearance process, with a decision code of SESE, indicating substantial equivalence. The device is used in anesthesiology and is designed to meet the needs of clinically practicing surgeons and anesthesiologists.
Frequently asked questions
What is the Tenax Laser Resistant Endotracheal Tube used for?
The Tenax Laser Resistant Endotracheal Tube is used in airway surgery to provide protection against surgical fires during laser surgery of the head and neck.
Is the Tenax Laser Resistant Endotracheal Tube supplied in different sizes?
Yes, the Tenax Laser Resistant Endotracheal Tube is supplied in 6 different sizes, all with a stylet.
Is the Tenax Laser Resistant Endotracheal Tube designed for single-use or reuse?
The Tenax Laser Resistant Endotracheal Tube is designed for single-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: Tenax™ Laser-Resistant Endotracheal Tube - DualCuff™ & Silicone Sheath ..., PDF BryanMedical_Tenax_Guide, BryanMedical TENAX Laser Resistant Endotracheal Tube, PDF Tenaxtm Tanex Laser Laser Resistant Resistant Endotracheal Endotracheal ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200761 | Class II | Active |
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Manufacturer
- Manufacturer
- Bryan Medical, Inc.
Sources (1)
- FDA 510(k) K200761 24 fields · synced Sep 21, 2026