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 a medical device manufactured by Rb Health (Us), LLC. It received FDA 510(k) clearance on 2020-04-14 under approval 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. It is manufactured by Rb Health (Us), LLC. The 510(k) number is K192982.
When was KY Grosz UltraGel approved by the FDA?
KY Grosz UltraGel received FDA 510(k) clearance on 2020-04-14, under approval number K192982.
What company makes KY Grosz UltraGel?
KY Grosz UltraGel is manufactured by Rb Health (Us), LLC.
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.