# K971509: Endoxane

- Pathway: 510(k) (Traditional)
- Applicant: Novatech SA
- Decided: Aug 21, 1997 after 118 days
- Product code: NWA (Prosthesis, Tracheal, Preformed/Molded)
- Device class: 2
- Regulation: 21 CFR 878.3720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K894380 (1989). 1 ancestor in all.
21 later devices descend from it; 6 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894380: Dumon Tracheobronchial Stent, Bryan Corp. (1989) Summary page 5.

## Most influential descendants
- K033053: Alveolus, TB-STS Tracheobronchial Stent System (2004), 15 descendants of its own
- K062511: Aero Tracheobronchial Stent System, Model 90129-2XX (2007), 14 descendants of its own
- K082284: Aero Tracheobronchial Stent Technology System (2008), 11 descendants of its own
- K083625: Aero DV Tracheobronchial Stent System (2009), 6 descendants of its own
- K121048: Ultraflex Tracheobronchial Stent System- Sterile Uncovered (2012), 5 descendants of its own

## Indications for use
The main indications according to their frequency are : 1. tracheobronchial tumors 2. Tracheal stenosis with scarring 3. Bronchial stenosis after surgical anastomotic, anastomoses resections or pulmonary transplantation. These stenoses have, as a common characteristic, the importance of the extrinsic compression or the collapse of the cartilingeous wall. The indication always focuses on an endoscopic therapeutic action, whether is concerns a resection or dilation. The stent insertion indication is indicated if the endoscopic resection is incomplete, in case of a persistent extrinsic compression, or if the lumen of the airway is insufficient. The most frequent locations are tracheal. The left main bronchus is the second location, followed by the right main bronchus.

Source page: https://510kreport.com/device/K971509
Methodology: https://510kreport.com/methodology