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FDA 510(k)

EndoNaut

K-Number: K222070 · 2022-10-25

ApplicantTherenva Sas
Decision Date2022-10-25
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EndoNaut is a medical device manufactured by Therenva Sas. It received FDA 510(k) clearance on 2022-10-25 under approval number K222070. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoNaut?

EndoNaut is a medical device that received FDA 510(k) clearance on 2022-10-25. It is manufactured by Therenva Sas. The 510(k) number is K222070.

When was EndoNaut approved by the FDA?

EndoNaut received FDA 510(k) clearance on 2022-10-25, under approval number K222070.

What company makes EndoNaut?

EndoNaut is manufactured by Therenva Sas.

What is the FDA product code for EndoNaut?

The FDA product code for EndoNaut is OWB.

Other Devices by Therenva Sas

K160376EndoSize K171829EndoNaut K212383EndoNaut

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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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