The following data is part of a premarket notification filed by Motus Gi Medical Technologies Ltd. with the FDA for Pure Vu.
Device ID | K160015 |
510k Number | K160015 |
Device Name: | Pure Vu |
Classification | Colonoscope And Accessories, Flexible/rigid |
Applicant | Motus GI Medical Technologies Ltd. 22 Keren Ha'yesod St. Tirat Carmel, IL 3902638 |
Contact | Hagit Ephrath |
Correspondent | Jonathan Kahan Hogan Lovells US LLP Columbia Square, 555 13th Street, NW Washington, DC 20004 |
Product Code | FDF |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-01-04 |
Decision Date | 2016-09-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05060513700120 | K160015 | 000 |
05060513700014 | K160015 | 000 |
05060513700021 | K160015 | 000 |
05060513700038 | K160015 | 000 |
05060513700090 | K160015 | 000 |
05060513700052 | K160015 | 000 |
05060513700083 | K160015 | 000 |
05060513700076 | K160015 | 000 |
05060513700113 | K160015 | 000 |
05060513700007 | K160015 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PURE VU 97620730 not registered Live/Pending |
REAH Group, LLC 2022-10-05 |
![]() PURE VU 90237554 not registered Live/Pending |
REAH Group LLC 2020-10-06 |