Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K222070 |
Device Name |
EndoNaut |
Applicant |
Therenva SAS |
74F rue de Paris |
Rennes,
FR
35000
|
|
Applicant Contact |
Audrey Gallois |
Correspondent |
Therenva SAS |
74F rue de Paris |
Rennes,
FR
35000
|
|
Correspondent Contact |
Cemil Goksu |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/14/2022 |
Decision Date | 10/25/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|