The following data is part of a premarket notification filed by Smart Medical Systems Ltd. with the FDA for G-eye System.
| Device ID | K202469 |
| 510k Number | K202469 |
| Device Name: | G-EYE System |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | SMART Medical Systems Ltd. 5 HaNofar Street Raanana, IL 4366404 |
| Contact | Adva Yoselzon |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, 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 | 2020-08-27 |
| Decision Date | 2020-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290018671504 | K202469 | 000 |
| 07290018671047 | K202469 | 000 |
| 07290018671030 | K202469 | 000 |
| 07290018671023 | K202469 | 000 |
| 07290018671016 | K202469 | 000 |
| 07290018671009 | K202469 | 000 |