Decision Date2022-02-17
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Titan Condoms is a medical device manufactured by Titan Condoms, LLC. It received FDA 510(k) clearance on 2022-02-17 under approval number K210208. 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 Titan Condoms?
Titan Condoms is a medical device that received FDA 510(k) clearance on 2022-02-17. It is manufactured by Titan Condoms, LLC. The 510(k) number is K210208.
When was Titan Condoms approved by the FDA?
Titan Condoms received FDA 510(k) clearance on 2022-02-17, under approval number K210208.
What company makes Titan Condoms?
Titan Condoms is manufactured by Titan Condoms, LLC.
What is the FDA product code for Titan Condoms?
The FDA product code for Titan Condoms is HIS.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.