QSM — System, Surgical, Computer Controlled Instrument, Remanufactured Class II
FDA product code QSM covers "System, Surgical, Computer Controlled Instrument, Remanufactured", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QSM
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
As intended with the originally cleared instrument.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252926 | Restore Robotics | Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical | Mar 26, 2026 |
| K250417 | Rebotix | Remanufactured EndoWrist Cobra Grasper (420190) | Aug 20, 2025 |
| K250399 | Rebotix | Remanufactured EndoWrist Cadiere Forceps (420049) | Aug 19, 2025 |
| K250539 | Rebotix | Remanufactured EndoWrist Tenaculum Forceps (420207) | Aug 19, 2025 |
| K250387 | Rebotix | Remanufactured EndoWrist Long Tip Forceps (420048) | Aug 19, 2025 |
| K242610 | Iconocare Health | 8mm Monopolar Curved Scissors (470179) | Mar 11, 2025 |
| K241872 | Rebotix | Remanufactured EndoWrist ProGrasp Forceps (420093) | Nov 7, 2024 |
| K210478 | Iconocare Health | 8mm Monopolar Curved Scissors | Sep 30, 2022 |