Home / 510(k) Clearances / K192684

510(k) K192684

HydroPearl Microspheres by MicroVention, Inc. — Product Code NOY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2020
Date Received
September 26, 2019
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 by MicroVention, Inc.

  • K243638 — MV Flow Aspiration Pump (MVFLOWPMP01) (June 13, 2025)
  • K232542 — Wedge XL Delivery Catheter (May 16, 2024)
  • K230775 — SOFIA EX Intracranial Support Catheter (September 14, 2023)
  • K222694 — EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) (April 27, 2023)
  • K222115 — ISAAC Neurovascular Navigation Catheter (January 10, 2023)
  • K223050 — AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880 (December 21, 2022)
  • K214024 — SOFIA 88 Catheter (September 12, 2022)
  • K211120 — ERIC Retrieval Device (March 31, 2022)
  • K193607 — BOBBY Balloon Guide Catheter (July 21, 2020)
  • K201487 — Traxcess 7 Mini Guidewire (July 2, 2020)

Other clearances for product code NOY

  • K203276 — Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - (April 20, 2021)
  • K180102 — Embozene Color-Advanced Microspheres (April 19, 2018)
  • DEN160040 — Embosphere Microspheres (June 21, 2017)