FDA 510(k) Application Details - K222070

Device Classification Name	More FDA Info for this Device
510(K) Number	K222070
Device Name	EndoNaut
Applicant	Therenva SAS 74F rue de Paris Rennes 35000 FR Other 510(k) Applications for this Company
Contact	Audrey Gallois Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2022
Decision Date	10/25/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review