K060323 is an FDA 510(k) clearance for the ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380. 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 May 12, 2006, 92 days after receiving the submission on February 9, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K060323 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2006 |
| Decision Date | May 12, 2006 |
| Days to Decision | 92 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 |