FDA product code QNM: Mountable Electromechanical Surgical System For Transluminal Approaches
QNM is the FDA product code for mountable electromechanical surgical system for transluminal approaches. It is a Class II device, regulated under 21 CFR 878.4961 and reviewed by the General and Plastic Surgery panel. FDA has cleared 7 510(k) submissions under QNM, 7 in the last five years. The average 510(k) review took 75 days (median 90); 81 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Mountable Electromechanical Surgical System For Transluminal Approaches |
| Device class | Class II |
| Regulation | 21 CFR 878.4961 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QNM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 57 |
| 2024 | 2 | 92 |
| 2025 | 4 | 70 |
Compare with all 510(k) review times · Search every QNM clearance
Top QNM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Momentis Surgical , Ltd. | 7 | 2025-07-08 |
Most recent QNM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251761 | Momentis Surgical , Ltd. | Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | 2025-07-08 | 29 |
| K250591 | Momentis Surgical , Ltd. | Anovo Surgical System (6Ne) | 2025-06-06 | 99 |
| K251056 | Momentis Surgical , Ltd. | Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | 2025-05-02 | 28 |
| K243182 | Momentis Surgical , Ltd. | Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode | 2025-02-03 | 126 |
| K242157 | Momentis Surgical , Ltd. | Anovo Surgical System (Model 6Ne) | 2024-10-21 | 90 |
Recalls for QNM devices
openFDA lists no recalls for product code QNM.
Frequently asked questions
What is FDA product code QNM?
QNM is the FDA product code for mountable electromechanical surgical system for transluminal approaches. It is a Class II device, regulated under 21 CFR 878.4961 and reviewed by the General and Plastic Surgery panel.
What device class is QNM?
Class II, regulation 21 CFR 878.4961. Typical premarket route: 510(k).
How long does a 510(k) take for product code QNM?
Across 7 cleared submissions the average was 75 days from receipt to decision (median 90).
Which companies have the most QNM clearances?
Momentis Surgical , Ltd. (7).
Next steps
- Run an FDA pathway report with predicate devices for product code QNM
- Run a recall and safety report across every QNM manufacturer
- Watch product code QNM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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