K180102 is an FDA 510(k) clearance for the Embozene Color-Advanced Microspheres. This device is classified as a Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia (Class II - Special Controls, product code NOY).
Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on April 19, 2018, 93 days after receiving the submission on January 16, 2018.
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 | K180102 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2018 |
| Decision Date | April 19, 2018 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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). |