Product code SDB— Anesthesiology
AMStent® Tracheobronchial Covered Stent System
- Classification name
- Tracheal Prosthesis With Cover Material Derived From Human Sources
- Device class
- Class 2
- Regulation
- 21 CFR 868.3721
- Advisory panel
- Anesthesiology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification definition
“The tracheal prosthesis with cover material derived from human sources is an expandable tubular device made of a metal material covered with a human-sourced decellularized material. It is intended to be implanted to restore the structure and/or function of the trachea or tracheobronchial tree. This device may also include a device delivery system. This device type does not include products that are intended to promote regeneration, impede inflammatory cascades, and release growth factors.”
Market context for product code SDB
FDA has cleared device under product code SDB, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SDB
Recent clearances under product code SDB
Data sourced from openFDA. This site is unofficial and independent of the FDA.