ProSeal Injection Site Extended Male Luer Lock (422140)
K-Number: K240433 · 2024-05-21
ApplicantEpic Medical Pte. , Ltd.
Decision Date2024-05-21
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
ProSeal Injection Site Extended Male Luer Lock (422140) is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2024-05-21 under approval number K240433. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ProSeal Injection Site Extended Male Luer Lock (422140)?
ProSeal Injection Site Extended Male Luer Lock (422140) is a medical device that received FDA 510(k) clearance on 2024-05-21. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K240433.
When was ProSeal Injection Site Extended Male Luer Lock (422140) approved by the FDA?
ProSeal Injection Site Extended Male Luer Lock (422140) received FDA 510(k) clearance on 2024-05-21, under approval number K240433.
What company makes ProSeal Injection Site Extended Male Luer Lock (422140)?
ProSeal Injection Site Extended Male Luer Lock (422140) is manufactured by Epic Medical Pte. , Ltd..
What is the FDA product code for ProSeal Injection Site Extended Male Luer Lock (422140)?
The FDA product code for ProSeal Injection Site Extended Male Luer Lock (422140) is ONB.
Related Clinical Trials
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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.