K233939 is an FDA 510(k) clearance for the Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System, a Prosthesis, Esophageal (Class II — Special Controls, product code ESW), submitted by Boston Scientific (Malborough, US). The FDA issued a Cleared decision on April 29, 2024, 137 days after receiving the submission on December 14, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K233939 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 14, 2023 |
| Decision Date | April 29, 2024 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ESW — Prosthesis, Esophageal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3610 |