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FDA 510(k)

KY Grosz Jelly

K-Number: K201186 · 2020-07-30

ApplicantRb Health (Us), LLC
Decision Date2020-07-30
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KY Grosz Jelly 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 2020-07-30 under 510(k) number K201186. 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 Jelly?

KY Grosz Jelly is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is Rb Health (Us), LLC. The 510(k) number is K201186.

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

KY Grosz Jelly received FDA 510(k) clearance on 2020-07-30, under 510(k) number K201186.

Who is the listed applicant for KY Grosz Jelly?

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 Jelly?

The FDA product code for KY Grosz Jelly 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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