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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 the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2020-01-22 under 510(k) 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. The listed applicant is MicroVention, Inc.. The 510(k) number is K192684.

When did HydroPearl Microspheres receive FDA 510(k) clearance?

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

Who is the listed applicant for HydroPearl Microspheres?

The FDA 510(k) record lists MicroVention, Inc. as the applicant. This does not by itself establish the device manufacturer.

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)

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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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