# K243126: Tracheobronxane™ Dumon®

- Pathway: 510(k) (Special)
- Applicant: Novatech SA
- Decided: Oct 29, 2024 after 29 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: 2 generations back to K894380 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971509: Endoxane, Novatech SA (1997) Summary page 6.

## Indications for use
For maintaining open the airway, after dilation of the stenosis or resection of the obstruction, in particular in case of: * Tracheobronchial tumors * Tracheal stenoses with scarring * Stenoses following surgical anastomosis, resektion or pulmonary transplantation

Source page: https://510kreport.com/device/K243126
Methodology: https://510kreport.com/methodology