DEN190022 is an FDA 510(k) submission for the Hominis Surgical System. This device is classified as a Mountable Electromechanical Surgical System For Transluminal Approaches (Class II - Special Controls, product code QNM).
Submitted by Momentis Surgical , Ltd. (Or Yehuda, IL). The FDA issued a Not Cleared (DENG) decision on February 26, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4961. A Mountable Electromechanical Surgical System For Transluminal Approaches Is A Software-controlled, Patient Bed- And/or Operating Table-mounted Electromechanical Surgical System With Human/device Interfaces That Allows A Qualified User To Perform Transluminal Endoscopic Or Laparoscopic Surgical Procedures Using Surgical Instruments Attached To An Electromechanical Arm..
| 510(k) Number | DEN190022 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 17, 2019 |
| Decision Date | February 26, 2021 |
| Days to Decision | 681 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | QNM - Mountable Electromechanical Surgical System For Transluminal Approaches |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4961 |
| Definition | A Mountable Electromechanical Surgical System For Transluminal Approaches Is A Software-controlled, Patient Bed- And/or Operating Table-mounted Electromechanical Surgical System With Human/device Interfaces That Allows A Qualified User To Perform Transluminal Endoscopic Or Laparoscopic Surgical Procedures Using Surgical Instruments Attached To An Electromechanical Arm. |