K203276 is an FDA 510(k) clearance for the Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml). This device is classified as a Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia (Class II - Special Controls, product code NOY).
Submitted by Biocompatibles UK Ltd (Part of Boston Scientific Corporation (Farnham, GB). The FDA issued a Cleared decision on April 20, 2021, 165 days after receiving the submission on November 6, 2020.
This device falls under the Neurology 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 | K203276 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2020 |
| Decision Date | April 20, 2021 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| 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). |