Embosphere Microspheres
FDA 510(k) clearance DEN160040 · decided 2017-06-21
Clearance details
- K-number
- DEN160040
- Device name
- Embosphere Microspheres
- Applicant
- Biosphere Medical, S.A.
- Decision
- Unknown
- Date received
- 2016-08-05
- Decision date
- 2017-06-21
- Days to decision
- 320 days
- Clearance type
- Direct
- Product code
- NOY
- Device class
- 2
- Regulation number
- 876.5550
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- 383 Rue De La Belle Etoile, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
Recalls involving this device
No recalls on record reference this clearance.