FDA 510(k)

EndoNaut

K-Number: K222070 · 2022-10-25

Decision Date2022-10-25

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EndoNaut is the device name listed in this FDA 510(k) record. The listed applicant is Therenva Sas. It received FDA 510(k) clearance on 2022-10-25 under 510(k) 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. The listed applicant is Therenva Sas. The 510(k) number is K222070.

When did EndoNaut receive FDA 510(k) clearance?

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

Who is the listed applicant for EndoNaut?

The FDA 510(k) record lists Therenva Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoNaut?

The FDA product code for EndoNaut is OWB.

Other records listing Therenva Sas as applicant

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.

K212383EndoNaut K171829EndoNaut K160376EndoSize

Related Devices (Code: OWB)

K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.K252503Intelligent NRCanon, Inc.K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.

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.