FDA 510(k)
FDA class 2
Unknown
🇫🇷 France
Embosphere Microspheres
K Number: DEN160040
·
Decision Jun 21, 2017
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
3
Applicant Total
10
Review Days
320
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Basic Information
- Device Name
- Embosphere Microspheres
- K Number
- DEN160040
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 876.5550
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Biosphere Medical, S.A.
- Date Received
- August 5, 2016
- Decision Date
- June 21, 2017
- Product Code
- NOY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NOY | Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NOY), ordered by most recent decision 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)
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FDA Class 2
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HydroPearl Microspheres
FDA 510(k)
FDA Class 2
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Embozene Color-Advanced Microspheres
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Biosphere Medical, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K250971 | Embosphere Microspheres | May 16, 2025 | Substantially Equivalent |
| K192480 | Torpedo Gelatin Foam | Nov 21, 2019 | Substantially Equivalent |
| K183120 | EmboCube Embolization Gelatin | Aug 6, 2019 | Substantially Equivalent |
| K183578 | Torpedo Gelatin Foam | Jun 18, 2019 | Substantially Equivalent |
| K181021 | EmboCube Embolization Gelatin | Sep 27, 2018 | Substantially Equivalent |
| K181300 | Embosphere Microspheres | Jul 16, 2018 | Substantially Equivalent |
| K172372 | QuadraSphere Microspheres | Sep 6, 2017 | Substantially Equivalent |
| K153102 | QuadraSphere Microspheres | Nov 23, 2015 | Substantially Equivalent |
| K151187 | QuadraSphere Microspheres | Jul 27, 2015 | Substantially Equivalent |