# Prosthesis, Tracheal, Expandable, Polymeric
> **Product code: NYT** · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.3720
## Classification
- **FDA Product Code:** NYT
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 878.3720
- **Review panel:** SU
- **Medical specialty:** General, Plastic Surgery
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

The device is intended to provide support to weakened or constricting airway walls and indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures, after all alternative therapies have been exhausted.

## Market data
- **Cleared 510(k) submissions:** 3
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NYT)
---
*AI Analytics · CC0 1.0*