DEN150040 is an FDA 510(k) submission for the WallFlex Biliary RX Fully Covered Stent System RMV. This device is classified as a Biliary Stent System For Benign Strictures (Class II - Special Controls, product code PNB).
Submitted by Boston Scientific (Marlboro, US). The FDA issued a Not Cleared (DENG) decision on June 3, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5011. A Benign Stricture Biliary Stent System Is A Prescription Device Intended For Treatment Of Benign Biliary Strictures. Stents Are Intended To Be Left Indwelling For A Limited Amount Of Time And Subsequently Removed. The Device Consists Of A Metal Stent And A Delivery System Intended To Place The Stent In The Biliary Ducts..
| 510(k) Number | DEN150040 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 28, 2015 |
| Decision Date | June 03, 2016 |
| Days to Decision | 280 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | PNB — Biliary Stent System For Benign Strictures |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5011 |
| Definition | A Benign Stricture Biliary Stent System Is A Prescription Device Intended For Treatment Of Benign Biliary Strictures. Stents Are Intended To Be Left Indwelling For A Limited Amount Of Time And Subsequently Removed. The Device Consists Of A Metal Stent And A Delivery System Intended To Place The Stent In The Biliary Ducts. |