K030769 is an FDA 510(k) clearance for the ULTRAFLEX PRECISION COLONIC STENT. 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 July 14, 2003, 125 days after receiving the submission on March 11, 2003.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K030769 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2003 |
| Decision Date | July 14, 2003 |
| Days to Decision | 125 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 |