The following data is part of a De Novo classification by Memic Innovative Surgery Ltd. with the FDA for Hominis Surgical System.
| DeNovo ID | DEN190022 |
| Device Name: | Hominis Surgical System |
| Classification | Mountable Electromechanical Surgical System For Transluminal Approaches |
| Applicant | Memic Innovative Surgery Ltd. 6 Yonatan Netanyahu Street Or Yehuda, IL 6037604 |
| Contact | Einav Yemini |
| Product Code | QNM |
| CFR Regulation Number | 878.4961 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Direct |
| Date Received | 2019-04-17 |
| Decision Date | 2021-02-26 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290018151154 | DEN190022 | 000 |
| 07290018151174 | DEN190022 | 000 |
| 17290018151164 | DEN190022 | 000 |
| 17290018151140 | DEN190022 | 000 |
| 17290018151133 | DEN190022 | 000 |
| 17290018151126 | DEN190022 | 000 |
| 17290018151119 | DEN190022 | 000 |
| 07290018151051 | DEN190022 | 000 |
| 07290018151044 | DEN190022 | 000 |
| 17290018151034 | DEN190022 | 000 |
| 17290018151188 | DEN190022 | 000 |
| 07290018151198 | DEN190022 | 000 |
| 27290018151109 | DEN190022 | 000 |
| 17290018151263 | DEN190022 | 000 |
| 17290018151096 | DEN190022 | 000 |
| 17290018151027 | DEN190022 | 000 |
| 17290018151249 | DEN190022 | 000 |
| 17290018151232 | DEN190022 | 000 |
| 07290018151228 | DEN190022 | 000 |
| 17290018151218 | DEN190022 | 000 |
| 17290018151201 | DEN190022 | 000 |
| 07290018151013 | DEN190022 | 000 |