Device Classification Name |
Colonoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K173392 |
Device Name |
Pure-Vu System |
Applicant |
Motus GI Medical Technologies Ltd. |
22 Keren Ha'yesod St. |
Tirat Carmel,
IL
3902638
|
|
Applicant Contact |
Hagit Ephrath |
Correspondent |
Hogan Lovells US LLP |
555 Thirteenth Street, NW |
Washington,
DC
20004
|
|
Correspondent Contact |
Hagit Ephrath |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/30/2017 |
Decision Date | 12/12/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|