Home / 510(k) Clearances / DEN160040

510(k) DEN160040

Embosphere Microspheres by Biosphere Medical, S.A. — Product Code NOY

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).

Other clearances by Biosphere Medical, S.A.

  • K250971 — Embosphere Microspheres (May 16, 2025)
  • K192480 — Torpedo Gelatin Foam (November 21, 2019)
  • K183120 — EmboCube Embolization Gelatin (August 6, 2019)
  • K183578 — Torpedo Gelatin Foam (June 18, 2019)
  • K181021 — EmboCube Embolization Gelatin (September 27, 2018)
  • K181300 — Embosphere Microspheres (July 16, 2018)
  • K172372 — QuadraSphere Microspheres (September 6, 2017)
  • K153102 — QuadraSphere Microspheres (November 23, 2015)
  • K151187 — QuadraSphere Microspheres (July 27, 2015)
  • K113822 — QUADRASPHERE 30 TO 60 (March 8, 2012)

Other clearances for product code NOY

  • K203276 — Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - (April 20, 2021)
  • K192684 — HydroPearl Microspheres (January 22, 2020)
  • K180102 — Embozene Color-Advanced Microspheres (April 19, 2018)