QNM — Mountable Electromechanical Surgical System For Transluminal Approaches Class II
FDA product code QNM covers "Mountable Electromechanical Surgical System For Transluminal Approaches", a Class II medical device regulated under 21 CFR 878.4961. Submissions are reviewed by the General, Plastic Surgery panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QNM
- Device Class
- Class II
- Regulation Number
- 878.4961
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251761 | momentis surgical | Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo | July 8, 2025 |
| K250591 | momentis surgical | Anovo Surgical System (6Ne) | June 6, 2025 |
| K251056 | momentis surgical | Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | May 2, 2025 |
| K243182 | momentis surgical | Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode | February 3, 2025 |
| K242157 | momentis surgical | Anovo Surgical System (Model 6Ne) | October 21, 2024 |
| K241907 | momentis surgical | Anovo Surgical System (model 6N) | October 2, 2024 |
| K232146 | momentis surgical | Anovo Pedestal | September 14, 2023 |
| DEN190022 | momentis surgical | Hominis Surgical System | February 26, 2021 |