510(k) K180102
K180102 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "Embozene Color-Advanced Microspheres". The FDA issued a decision of Substantially Equivalent on April 19, 2018. 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. Boston Scientific has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 2018
- Date Received
- January 16, 2018
- Clearance Type
- Traditional
- 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).