NOY — Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia Class II
Classification Details
- Product Code
- NOY
- Device Class
- Class II
- Regulation Number
- 876.5550
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K203276 | biocompatibles uk ltd (part of boston scientific corporation | Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - | April 20, 2021 |
| K192684 | microvention | HydroPearl Microspheres | January 22, 2020 |
| K180102 | boston scientific | Embozene Color-Advanced Microspheres | April 19, 2018 |
| DEN160040 | biosphere medical | Embosphere Microspheres | June 21, 2017 |