Data / Medical devices / United States / Restore Robotics Repairs LLC
Restore Robotics Repairs LLC: FDA-registered device maker in Henderson, NV, United States, 3 510(k) clearances
Restore Robotics Repairs LLC is registered with the FDA (registration 3036035332) in Henderson, NV, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 26, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3036035332
- Address
- 15 Longevity Dr. Building C, Henderson, NV, United States, 89014
- Owner or operator
- Restore Robotics Repairs LLC (10092684)
- Roles
- Remanufacturer
- First device listed
- February 5, 2025
- Registered through
- 2027
- Brand names listed
- Restore Robotics, Robotic Surgical Instruments - Permanent Cautery Hook (470183), Robotic Surgical Instruments - Permanent Cautery Spatula (470184)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Surgical, Computer Controlled Instrument | NAY | 2 | Remanufacturer | accessdata.fda.gov |
| System, Surgical, Computer Controlled Instrument, Remanufactured | QSM | 2 | Remanufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 26, 2026 | K252926 | Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) | QSM | Substantially Equivalent | Restore Robotics | accessdata.fda.gov |
| March 11, 2025 | K242610 | 8mm Monopolar Curved Scissors (470179) | QSM | Substantially Equivalent | Iconocare Health | accessdata.fda.gov |
| September 30, 2022 | K210478 | 8mm Monopolar Curved Scissors | QSM | Substantially Equivalent | Iconocare Health | accessdata.fda.gov |
Compare with other makers
Updated March 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.