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FDA 510(k)

KY Grosz UltraGel

K-Number: K192982 · 2020-04-14

ApplicantRb Health (Us), LLC
Decision Date2020-04-14
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KY Grosz UltraGel is the device name listed in this FDA 510(k) record. The listed applicant is Rb Health (Us), LLC. It received FDA 510(k) clearance on 2020-04-14 under 510(k) number K192982. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KY Grosz UltraGel?

KY Grosz UltraGel is a medical device that received FDA 510(k) clearance on 2020-04-14. The listed applicant is Rb Health (Us), LLC. The 510(k) number is K192982.

When did KY Grosz UltraGel receive FDA 510(k) clearance?

KY Grosz UltraGel received FDA 510(k) clearance on 2020-04-14, under 510(k) number K192982.

Who is the listed applicant for KY Grosz UltraGel?

The FDA 510(k) record lists Rb Health (Us), LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KY Grosz UltraGel?

The FDA product code for KY Grosz UltraGel is NUC.

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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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