510(k) clearance
Tenax® Laser Resistant Endotracheal Tube
- 510(k) number
- K251794
- Applicant
- Bryan Medical, Inc.
- Decision date
- Sep 3, 2026
- Date received
- Jun 12, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- BTR
- Device type
- Tube, Tracheal (W/Wo Connector)
- Device class
- Class II
- Regulation
- 21 CFR 868.5730
- Advisory committee
- Anesthesiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Cincinnati, OH, US