K200257 is an FDA 510(k) clearance for the WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System. This device is classified as a Stent, Colonic, Metallic, Expandable (Class II - Special Controls, product code MQR).
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on April 17, 2020, 74 days after receiving the submission on February 3, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K200257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2020 |
| Decision Date | April 17, 2020 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MQR — Stent, Colonic, Metallic, Expandable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3610 |