K954290 is an FDA 510(k) clearance for the WALLSTENT ENTERAL ENDOPROTHESIS. This device is classified as a Stent, Colonic, Metallic, Expandable (Class II - Special Controls, product code MQR).
Submitted by Boston Scientific Scimed, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 10, 1996, 300 days after receiving the submission on September 14, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K954290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 1995 |
| Decision Date | July 10, 1996 |
| Days to Decision | 300 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 |