Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K193600 |
Device Name |
EndoGI Biliary Stent System |
Applicant |
EndoGI Medical, Ltd. |
13 Wadi El Hadj |
Nazareth,
IL
|
|
Applicant Contact |
Omri Naveh |
Correspondent |
ProMedoss, Inc |
3521 Hatwynn Rd. |
Charlotte,
NC
28269
|
|
Correspondent Contact |
Bosmat Friedman |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 12/23/2019 |
Decision Date | 06/26/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|