EndoNaut
K-Number: K171829 · 2017-09-21
ApplicantTherenva Sas
Decision Date2017-09-21
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EndoNaut is a medical device manufactured by Therenva Sas. It received FDA 510(k) clearance on 2017-09-21 under approval number K171829. 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 2017-09-21. It is manufactured by Therenva Sas. The 510(k) number is K171829.
When was EndoNaut approved by the FDA?
EndoNaut received FDA 510(k) clearance on 2017-09-21, under approval number K171829.
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.
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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.