NOY
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5550
- Medical specialty
- Gastroenterology, Urology
- Flags
- Implant
- FDA 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).
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| 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) (K203276) | Biocompatibles UK Ltd (Part of Boston Scientific Corporation | 2021-04-20 |
| HydroPearl Microspheres (K192684) | MicroVention, Inc. | 2020-01-22 |
| Embozene Color-Advanced Microspheres (K180102) | Boston Scientific | 2018-04-19 |
| Embosphere Microspheres (DEN160040) | Biosphere Medical, S.A. | 2017-06-21 |
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Every clearance here is in the API, with alerts when new ones post.