Durex Patronus Wide
K-Number: K213647 · 2022-02-17
ApplicantRb Health (Us), LLC
Decision Date2022-02-17
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Durex Patronus Wide is a medical device manufactured by Rb Health (Us), LLC. It received FDA 510(k) clearance on 2022-02-17 under approval number K213647. 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 Wide?
Durex Patronus Wide is a medical device that received FDA 510(k) clearance on 2022-02-17. It is manufactured by Rb Health (Us), LLC. The 510(k) number is K213647.
When was Durex Patronus Wide approved by the FDA?
Durex Patronus Wide received FDA 510(k) clearance on 2022-02-17, under approval number K213647.
What company makes Durex Patronus Wide?
Durex Patronus Wide is manufactured by Rb Health (Us), LLC.
What is the FDA product code for Durex Patronus Wide?
The FDA product code for Durex Patronus Wide 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.