K013266 is an FDA 510(k) clearance for the RUSCH POLYFLEX STENT KIT. This device is classified as a Prosthesis, Tracheal, Expandable, Polymeric (Class II - Special Controls, product code NYT).
Submitted by Rusch Intl. (Jaffrey, US). The FDA issued a Cleared decision on November 27, 2001, 57 days after receiving the submission on October 1, 2001.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3720. 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..
| 510(k) Number | K013266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2001 |
| Decision Date | November 27, 2001 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NYT — Prosthesis, Tracheal, Expandable, Polymeric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3720 |
| 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. |