FDA product code SDB: Tracheal Prosthesis With Cover Material Derived From Human Sources

SDB is the FDA product code for tracheal prosthesis with cover material derived from human sources. It is a Class II device, regulated under 21 CFR 868.3721 and reviewed by the Anesthesiology panel. Devices under SDB reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for SDB devices

openFDA lists no recalls for product code SDB.

Frequently asked questions

What is FDA product code SDB?

SDB is the FDA product code for tracheal prosthesis with cover material derived from human sources. It is a Class II device, regulated under 21 CFR 868.3721 and reviewed by the Anesthesiology panel.

What device class is SDB?

Class II, regulation 21 CFR 868.3721. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code SDB
• Run a recall and safety report across every SDB manufacturer
• Watch product code SDB for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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