510(k) K203276
K203276 is an FDA 510(k) premarket notification submitted by Biocompatibles UK Ltd (Part of Boston Scientific Corporation for the device "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)". The FDA issued a decision of Substantially Equivalent on April 20, 2021. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2021
- Date Received
- November 6, 2020
- 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).