K042065 is an FDA 510(k) clearance for the WALLFLEX ENTERNAL COLONIC STENT AND 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 Corp (Natick,, US). The FDA issued a Cleared decision on September 30, 2004, 59 days after receiving the submission on August 2, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K042065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2004 |
| Decision Date | September 30, 2004 |
| Days to Decision | 59 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 |