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FDA 510(k)

Endorail

K-Number: K232327 · 2024-03-15

ApplicantEndostart S.R.L.
Decision Date2024-03-15
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endorail is a medical device manufactured by Endostart S.R.L.. It received FDA 510(k) clearance on 2024-03-15 under approval number K232327. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endorail?

Endorail is a medical device that received FDA 510(k) clearance on 2024-03-15. It is manufactured by Endostart S.R.L.. The 510(k) number is K232327.

When was Endorail approved by the FDA?

Endorail received FDA 510(k) clearance on 2024-03-15, under approval number K232327.

What company makes Endorail?

Endorail is manufactured by Endostart S.R.L..

What is the FDA product code for Endorail?

The FDA product code for Endorail is ODC.

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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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