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FDA 510(k)

Endofill

K-Number: K231387 · 2023-07-10

ApplicantLumendo AG
Decision Date2023-07-10
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Endofill is a medical device manufactured by Lumendo AG. It received FDA 510(k) clearance on 2023-07-10 under approval number K231387. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endofill?

Endofill is a medical device that received FDA 510(k) clearance on 2023-07-10. It is manufactured by Lumendo AG. The 510(k) number is K231387.

When was Endofill approved by the FDA?

Endofill received FDA 510(k) clearance on 2023-07-10, under approval number K231387.

What company makes Endofill?

Endofill is manufactured by Lumendo AG.

What is the FDA product code for Endofill?

The FDA product code for Endofill is KIF.

Other Devices by Lumendo AG

K232076Fibercure

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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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