Mountable Electromechanical Surgical System For Transluminal Approaches
QNM is the FDA product code for Mountable Electromechanical Surgical System For Transluminal Approaches, a class II device type, regulated under 21 CFR 878.4961. FDA's definition for this code reads: "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...". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QNM
- Device name
- Mountable Electromechanical Surgical System For Transluminal Approaches
- FDA 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.
- Regulation
- 21 CFR 878.4961
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 8
- Ingested recalls
- 0
Clearances, product code QNM
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 4 |
Applicants with the most clearances
Product code QNM| Applicant | Clearances |
|---|---|
| Momentis Surgical Ltd. | 8 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
