K250591 is an FDA 510(k) clearance for the Anovo Surgical System (6Ne). 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 Cleared decision on June 6, 2025, 99 days after receiving the submission on February 27, 2025.
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 | K250591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2025 |
| Decision Date | June 06, 2025 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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. |