DiLumen C2 and Tool Mount
K-Number: K211819 · 2021-10-22
ApplicantLumendi, LLC
Decision Date2021-10-22
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
DiLumen C2 and Tool Mount is a medical device manufactured by Lumendi, LLC. It received FDA 510(k) clearance on 2021-10-22 under approval number K211819. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DiLumen C2 and Tool Mount?
DiLumen C2 and Tool Mount is a medical device that received FDA 510(k) clearance on 2021-10-22. It is manufactured by Lumendi, LLC. The 510(k) number is K211819.
When was DiLumen C2 and Tool Mount approved by the FDA?
DiLumen C2 and Tool Mount received FDA 510(k) clearance on 2021-10-22, under approval number K211819.
What company makes DiLumen C2 and Tool Mount?
DiLumen C2 and Tool Mount is manufactured by Lumendi, LLC.
What is the FDA product code for DiLumen C2 and Tool Mount?
The FDA product code for DiLumen C2 and Tool Mount is FDF.
Other Devices by Lumendi, LLC
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K183112DiLumen Endolumenal Interventional Knife (DiLumen IK)
K210851DiLumen Endolumenal Interventional Platform (DiLumen)
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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.