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FDA 510(k)

ENDOtube

K-Number: K203350 · 2021-09-29

ApplicantNissha Medical Technologies Sas
Decision Date2021-09-29
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOtube is a medical device manufactured by Nissha Medical Technologies Sas. It received FDA 510(k) clearance on 2021-09-29 under approval number K203350. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOtube?

ENDOtube is a medical device that received FDA 510(k) clearance on 2021-09-29. It is manufactured by Nissha Medical Technologies Sas. The 510(k) number is K203350.

When was ENDOtube approved by the FDA?

ENDOtube received FDA 510(k) clearance on 2021-09-29, under approval number K203350.

What company makes ENDOtube?

ENDOtube is manufactured by Nissha Medical Technologies Sas.

What is the FDA product code for ENDOtube?

The FDA product code for ENDOtube is OCX.

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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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