K081768 is an FDA 510(k) clearance for the COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES. This device is classified as a Agents, Embolic, For Treatment Of Uterine Fibroids (Class II - Special Controls, product code NAJ).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on December 23, 2008, 186 days after receiving the submission on June 20, 2008.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K081768 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2008 |
| Decision Date | December 23, 2008 |
| Days to Decision | 186 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 |