Embozene Color-Advanced Microspheres
FDA 510(k) clearance K180102 · decided 2018-04-19
Clearance details
- K-number
- K180102
- Device name
- Embozene Color-Advanced Microspheres
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2018-01-16
- Decision date
- 2018-04-19
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- NOY
- Device class
- 2
- Regulation number
- 876.5550
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Boston Scientific
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| Embosphere Microspheres (DEN160040) | Biosphere Medical, S.A. | 2017-06-21 |
Recalls involving this device
No recalls on record reference this clearance.