510(k) K250387
- Device
- Remanufactured EndoWrist Long Tip Forceps (420048)
- Applicant
- Rebotix
- 510(k) number
- K250387
- Product code
- QSM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-19
- Date received
- 2025-02-11
- Regulation
- 876.1500
- Classification name
- System, Surgical, Computer Controlled Instrument, Remanufactured
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Chris Gibson
- Address
- 539 Pasadena Ave. S. St. Petersburg FL US 33707 33707
FDA Registration Numbers#
- 3036035332
Source Documents#
Other 510(k) Records For Product Code QSM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252926 | Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) | Restore Robotics | 2026-03-26 |
| K250417 | Remanufactured EndoWrist Cobra Grasper (420190) | Rebotix | 2025-08-20 |
| K250399 | Remanufactured EndoWrist Cadiere Forceps (420049) | Rebotix | 2025-08-19 |
| K250539 | Remanufactured EndoWrist Tenaculum Forceps (420207) | Rebotix | 2025-08-19 |
| K242610 | 8mm Monopolar Curved Scissors (470179) | Iconocare Health | 2025-03-11 |
| K241872 | Remanufactured EndoWrist ProGrasp Forceps (420093) | Rebotix | 2024-11-07 |
| K210478 | 8mm Monopolar Curved Scissors | Iconocare Health | 2022-09-30 |