FDA product code NYT: Prosthesis, Tracheal, Expandable, Polymeric
NYT is the FDA product code for prosthesis, tracheal, expandable, polymeric. It is a Class II device, regulated under 21 CFR 878.3720 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under NYT, from 2 different applicants. The average 510(k) review took 87 days (median 74).
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.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Tracheal, Expandable, Polymeric |
| Device class | Class II |
| Regulation | 21 CFR 878.3720 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every NYT clearance
Top NYT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rusch Intl. | 2 | 2001-11-27 |
| Rusch, Inc. | 1 | 1995-10-13 |
Most recent NYT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013266 | Rusch Intl. | RUSCH POLYFLEX STENT KIT | 2001-11-27 | 57 |
| K982614 | Rusch Intl. | RUSCH POLYFLEX STENT KIT | 1998-12-04 | 130 |
| K953593 | Rusch, Inc. | RUSCH TRACHEAL BRONCHIAL Y STENT | 1995-10-13 | 74 |
Recalls for NYT devices
openFDA lists no recalls for product code NYT.
Frequently asked questions
What is FDA product code NYT?
NYT is the FDA product code for prosthesis, tracheal, expandable, polymeric. It is a Class II device, regulated under 21 CFR 878.3720 and reviewed by the General and Plastic Surgery panel.
What device class is NYT?
Class II, regulation 21 CFR 878.3720. Typical premarket route: 510(k).
How long does a 510(k) take for product code NYT?
Across 3 cleared submissions the average was 87 days from receipt to decision (median 74).
Which companies have the most NYT clearances?
Rusch Intl. (2); Rusch, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NYT
- Run a recall and safety report across every NYT manufacturer
- Watch product code NYT 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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