FDA 510(k)

Endorail

K-Number: K232327 · 2024-03-15

Decision Date2024-03-15

Product CodeODC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Endorail is the device name listed in this FDA 510(k) record. The listed applicant is Endostart S.R.L.. It received FDA 510(k) clearance on 2024-03-15 under 510(k) 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. The listed applicant is Endostart S.R.L.. The 510(k) number is K232327.

When did Endorail receive FDA 510(k) clearance?

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

Who is the listed applicant for Endorail?

The FDA 510(k) record lists Endostart S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endorail?

The FDA product code for Endorail is ODC.

Related Devices (Code: ODC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.