FDA Product Code
FDA Product Code NOY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5550
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203276 | 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) | Biocompatibles UK Ltd (Part of Boston Scientific Corporation | 2021-04-20 | Traditional | PDF ↗ |
| K192684 | HydroPearl Microspheres | MicroVention, Inc. | 2020-01-22 | Traditional | PDF ↗ |
| K180102 | Embozene Color-Advanced Microspheres | Boston Scientific | 2018-04-19 | Traditional | PDF ↗ |
| DEN160040 | Embosphere Microspheres | Biosphere Medical, S.A. | 2017-06-21 | Direct | — |
Product code NOY · Class II · Gastroenterology, Urology. Data: openFDA.