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FDA 510(k)

HydroPearl Microspheres

K-Number: K192684 · 2020-01-22

ApplicantMicroVention, Inc.
Decision Date2020-01-22
Product CodeNOY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HydroPearl Microspheres is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2020-01-22 under approval number K192684. The device is classified under product code NOY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HydroPearl Microspheres?

HydroPearl Microspheres is a medical device that received FDA 510(k) clearance on 2020-01-22. It is manufactured by MicroVention, Inc.. The 510(k) number is K192684.

When was HydroPearl Microspheres approved by the FDA?

HydroPearl Microspheres received FDA 510(k) clearance on 2020-01-22, under approval number K192684.

What company makes HydroPearl Microspheres?

HydroPearl Microspheres is manufactured by MicroVention, Inc..

What is the FDA product code for HydroPearl Microspheres?

The FDA product code for HydroPearl Microspheres is NOY.

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Related Devices (Code: NOY)

DEN160040Embosphere MicrospheresBiosphere Medical, S.A. K180102Embozene Color-Advanced MicrospheresBoston Scientific 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 Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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