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510(k) K192684

Device
HydroPearl Microspheres
Applicant
MicroVention, Inc.
510(k) number
K192684
Product code
NOY  
Decision
Substantially Equivalent (SESE)
Decision date
2020-01-22
Date received
2019-09-26
Regulation
876.5550
Classification name
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Analia Staubly
Address
35 Enterprise Aliso Viejo CA US 92656 92656

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NOY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203276Bead 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)Biocompatibles UK Ltd (Part of Boston Scientific Corporation2021-04-20
K180102Embozene Color-Advanced MicrospheresBoston Scientific2018-04-19
DEN160040Embosphere MicrospheresBiosphere Medical, S.A.2017-06-21

Legacy Summary#

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FDA Review#

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