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FDA 510(k)

DiLumen C2; DiLumen Tool Mount

K-Number: K173317 · 2018-04-17

ApplicantLumendi, LLC
Decision Date2018-04-17
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DiLumen C2; DiLumen Tool Mount is a medical device manufactured by Lumendi, LLC. It received FDA 510(k) clearance on 2018-04-17 under approval number K173317. 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; DiLumen Tool Mount?

DiLumen C2; DiLumen Tool Mount is a medical device that received FDA 510(k) clearance on 2018-04-17. It is manufactured by Lumendi, LLC. The 510(k) number is K173317.

When was DiLumen C2; DiLumen Tool Mount approved by the FDA?

DiLumen C2; DiLumen Tool Mount received FDA 510(k) clearance on 2018-04-17, under approval number K173317.

What company makes DiLumen C2; DiLumen Tool Mount?

DiLumen C2; DiLumen Tool Mount is manufactured by Lumendi, LLC.

What is the FDA product code for DiLumen C2; DiLumen Tool Mount?

The FDA product code for DiLumen C2; DiLumen Tool Mount is FDF.

Other Devices by Lumendi, LLC

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Related Devices (Code: FDF)

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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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