Data / Medical devices / United States / Virtual Incision Corporation
Virtual Incision Corporation: FDA-registered device maker in Lincoln, NE, United States, 1 510(k) clearance
Virtual Incision Corporation is registered with the FDA (registration 3030285773) in Lincoln, NE, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 23, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030285773
- Address
- 1501 Old Cheney Rd, Lincoln, NE, United States, 68512
- Owner or operator
- Virtual Incision Corporation (10090552)
- Roles
- Manufacturer
- First device listed
- April 11, 2024
- Registered through
- 2026
- Brand names listed
- MIRA Surgical System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Table Mounted Miniaturized Electromechanical Surgical System | SAB | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 23, 2024 | DEN230025 | MIRA Surgical System | SAB | Unknown | Virtual Incision | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 23, 2025 | 96831 | Class II | Completed | MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3 | The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen, caused by a software latency between the movement of the hand controllers and the movement of the Surgical Minibot arms. | accessdata.fda.gov |
Updated June 4, 2025. 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.