K100663 is an FDA 510(k) clearance for the CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321. This device is classified as a Agents, Embolic, For Treatment Of Uterine Fibroids (Class II - Special Controls, product code NAJ).
Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on April 16, 2010, 39 days after receiving the submission on March 8, 2010.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K100663 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2010 |
| Decision Date | April 16, 2010 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | NAJ — Agents, Embolic, For Treatment Of Uterine Fibroids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3300 |