QSM
- Product code
- QSM
- Device name
- System, Surgical, Computer Controlled Instrument, Remanufactured
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 8 (all years; only the last 3 years are listed here)
FDA classification definition
As intended with the originally cleared instrument.
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252926 | 2026-03-26 | Restore Robotics | Robotic Surgical Instruments - Permanent Cautery Hoo… | |
| K250417 | 2025-08-20 | Rebotix | Remanufactured EndoWrist Cobra Grasper (420190) | |
| K250539 | 2025-08-19 | Rebotix | Remanufactured EndoWrist Tenaculum Forceps (420207) | |
| K250399 | 2025-08-19 | Rebotix | Remanufactured EndoWrist Cadiere Forceps (420049) | |
| K250387 | 2025-08-19 | Rebotix | Remanufactured EndoWrist Long Tip Forceps (420048) | FDA |
| K242610 | 2025-03-11 | Iconocare Health | 8mm Monopolar Curved Scissors (470179) | |
| K241872 | 2024-11-07 | Rebotix | Remanufactured EndoWrist ProGrasp Forceps (420093) |
Official FDA classification page: QSM
Classification and pathway per current FDA publications. Data from openFDA (CC0).