FDA product code QSM: System, Surgical, Computer Controlled Instrument, Remanufactured
QSM is the FDA product code for system, surgical, computer controlled instrument, remanufactured. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under QSM, 8 in the last five years, from 3 different applicants. The average 510(k) review took 230 days (median 188); 170 days on average over the last three years.
Definition
As intended with the originally cleared instrument.
Classification
| Field | Value |
|---|---|
| Device name | System, Surgical, Computer Controlled Instrument, Remanufactured |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QSM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 588 |
| 2024 | 1 | 133 |
| 2025 | 5 | 186 |
| 2026 | 1 | 192 |
Compare with all 510(k) review times · Search every QSM clearance
Top QSM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rebotix | 5 | 2025-08-20 |
| Iconocare Health | 2 | 2025-03-11 |
| Restore Robotics | 1 | 2026-03-26 |
Most recent QSM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252926 | Restore Robotics | Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) | 2026-03-26 | 192 |
| K250417 | Rebotix | Remanufactured EndoWrist Cobra Grasper (420190) | 2025-08-20 | 188 |
| K250387 | Rebotix | Remanufactured EndoWrist Long Tip Forceps (420048) | 2025-08-19 | 189 |
| K250399 | Rebotix | Remanufactured EndoWrist Cadiere Forceps (420049) | 2025-08-19 | 188 |
| K250539 | Rebotix | Remanufactured EndoWrist Tenaculum Forceps (420207) | 2025-08-19 | 176 |
Recalls for QSM devices
openFDA lists no recalls for product code QSM.
Frequently asked questions
What is FDA product code QSM?
QSM is the FDA product code for system, surgical, computer controlled instrument, remanufactured. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel.
What device class is QSM?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code QSM?
Across 8 cleared submissions the average was 230 days from receipt to decision (median 188).
Which companies have the most QSM clearances?
Rebotix (5); Iconocare Health (2); Restore Robotics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QSM
- Run a recall and safety report across every QSM manufacturer
- Watch product code QSM 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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