510(k) DEN160040
DEN160040 is an FDA 510(k) premarket notification submitted by Biosphere Medical, S.A. for the device "Embosphere Microspheres". The FDA issued a decision of De Novo Granted on June 21, 2017. The device falls under product code NOY (Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia), a Class II device regulated under 21 CFR 876.5550. Biosphere Medical, S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 21, 2017
- Date Received
- August 5, 2016
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
- Device Class
- Class II
- Regulation Number
- 876.5550
- Review Panel
- GU
- Submission Type
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).