DEN160040 is an FDA 510(k) submission for the Embosphere Microspheres. This device is classified as a Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia (Class II - Special Controls, product code NOY).
Submitted by Biosphere Medical, S.A. (383 Rue De La Belle Etoile, FR). The FDA issued a Not Cleared (DENG) decision on June 21, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5550. The Device Comprises One Or More Objects Placed In A Blood Vessel To Permanently Obstruct Blood Flow To The Prostate To Treat Benign Prostatic Hyperplasia (bph)..
| 510(k) Number | DEN160040 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 05, 2016 |
| Decision Date | June 21, 2017 |
| Days to Decision | 320 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | NOY - Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5550 |
| Definition | The Device Comprises One Or More Objects Placed In A Blood Vessel To Permanently Obstruct Blood Flow To The Prostate To Treat Benign Prostatic Hyperplasia (bph). |