K971509 is an FDA 510(k) clearance for the ENDOXANE. This device is classified as a Prosthesis, Tracheal, Preformed/molded (Class II - Special Controls, product code NWA).
Submitted by Novatech SA (Aubagne, FR). The FDA issued a Cleared decision on August 21, 1997, 118 days after receiving the submission on April 25, 1997.
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..
| 510(k) Number | K971509 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | April 25, 1997 |
| Decision Date | August 21, 1997 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | NWA - Prosthesis, Tracheal, Preformed/molded |
| 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. |