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FDA 510(k)

Durex Patronus CloseFit, Durex Patronus Regular

K-Number: K220489 · 2022-11-07

ApplicantRb Health (Us), LLC
Decision Date2022-11-07
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Durex Patronus CloseFit, Durex Patronus Regular is a medical device manufactured by Rb Health (Us), LLC. It received FDA 510(k) clearance on 2022-11-07 under approval number K220489. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Durex Patronus CloseFit, Durex Patronus Regular?

Durex Patronus CloseFit, Durex Patronus Regular is a medical device that received FDA 510(k) clearance on 2022-11-07. It is manufactured by Rb Health (Us), LLC. The 510(k) number is K220489.

When was Durex Patronus CloseFit, Durex Patronus Regular approved by the FDA?

Durex Patronus CloseFit, Durex Patronus Regular received FDA 510(k) clearance on 2022-11-07, under approval number K220489.

What company makes Durex Patronus CloseFit, Durex Patronus Regular?

Durex Patronus CloseFit, Durex Patronus Regular is manufactured by Rb Health (Us), LLC.

What is the FDA product code for Durex Patronus CloseFit, Durex Patronus Regular?

The FDA product code for Durex Patronus CloseFit, Durex Patronus Regular is HIS.

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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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