The following data is part of a premarket notification filed by Smart Medical Systems Ltd. with the FDA for G-eye System.
| Device ID | K192588 |
| 510k Number | K192588 |
| Device Name: | G-EYE System |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | SMART Medical Systems Ltd. 5 HaNofar St. Raanana, IL 4366404 |
| Contact | Adva Yoselzon |
| Correspondent | Janice Hogan Hogan Lovells US LPP 1735 Market Street Floor 23 Philladelphia, PA 19103 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-19 |
| Decision Date | 2020-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290018671153 | K192588 | 000 |
| 07290018671061 | K192588 | 000 |
| 07290018671078 | K192588 | 000 |
| 07290018671085 | K192588 | 000 |
| 07290018671092 | K192588 | 000 |
| 07290018671108 | K192588 | 000 |
| 07290018671115 | K192588 | 000 |
| 07290018671122 | K192588 | 000 |
| 07290018671139 | K192588 | 000 |
| 07290018671146 | K192588 | 000 |
| 07290018671054 | K192588 | 000 |