QSM
8 FDA 510(k) clearances · Product code
189 daysmedian time to decision
588 days90th percentile
8clearances measured
FDA profile
- Official device name
- System, Surgical, Computer Controlled Instrument, Remanufactured
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- As intended with the originally cleared instrument.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) (K252926) | Restore Robotics | 2026-03-26 |
| Remanufactured EndoWrist Cobra Grasper (420190) (K250417) | Rebotix | 2025-08-20 |
| Remanufactured EndoWrist Tenaculum Forceps (420207) (K250539) | Rebotix | 2025-08-19 |
| Remanufactured EndoWrist Long Tip Forceps (420048) (K250387) | Rebotix | 2025-08-19 |
| Remanufactured EndoWrist Cadiere Forceps (420049) (K250399) | Rebotix | 2025-08-19 |
| 8mm Monopolar Curved Scissors (470179) (K242610) | Iconocare Health | 2025-03-11 |
| Remanufactured EndoWrist ProGrasp Forceps (420093) (K241872) | Rebotix | 2024-11-07 |
| 8mm Monopolar Curved Scissors (K210478) | Iconocare Health | 2022-09-30 |
Track QSM automatically
Every clearance here is in the API, with alerts when new ones post.