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510(k) K203276

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) by Biocompatibles UK Ltd (Part of Boston Scientific Corporation — Product Code NOY

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).

Other clearances for product code NOY

  • K192684 — HydroPearl Microspheres (January 22, 2020)
  • K180102 — Embozene Color-Advanced Microspheres (April 19, 2018)
  • DEN160040 — Embosphere Microspheres (June 21, 2017)