Device class
Class II
Regulation 876.1500
Total clearances
8
2022-09-30 → 2026-03-26
Definition
What is System, Surgical, Computer Controlled Instrument, Remanufactured
As intended with the originally cleared instrument.
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.1500
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Rebotix
|
5 |
0 |
2025-08-20 |
|
Iconocare Health |
2 |
0 |
2025-03-11 |
|
Restore Robotics |
1 |
1 |
2026-03-26 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 43644 |
CPT
|
— |
Low
|
Remanufactured surgical instrument; actual billing code depends on original device procedure |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-03-26 |
K252926 |
Restore Robotics
|
Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) |
| 2025-08-20 |
K250417 |
Rebotix
|
Remanufactured EndoWrist Cobra Grasper (420190) |
| 2025-08-19 |
K250539 |
Rebotix
|
Remanufactured EndoWrist Tenaculum Forceps (420207) |
| 2025-08-19 |
K250399 |
Rebotix
|
Remanufactured EndoWrist Cadiere Forceps (420049) |
| 2025-08-19 |
K250387 |
Rebotix
|
Remanufactured EndoWrist Long Tip Forceps (420048) |
| 2025-03-11 |
K242610 |
Iconocare Health
|
8mm Monopolar Curved Scissors (470179) |
| 2024-11-07 |
K241872 |
Rebotix
|
Remanufactured EndoWrist ProGrasp Forceps (420093) |
| 2022-09-30 |
K210478 |
Iconocare Health
|
8mm Monopolar Curved Scissors |