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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 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 2022-11-07 under 510(k) 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. The listed applicant is Rb Health (Us), LLC. The 510(k) number is K220489.

When did Durex Patronus CloseFit, Durex Patronus Regular receive FDA 510(k) clearance?

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

Who is the listed applicant for Durex Patronus CloseFit, Durex Patronus Regular?

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 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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