510(k) K260817
- Device
- MIRA Surgical System
- Applicant
- Virtual Incision
- 510(k) number
- K260817
- Product code
- SAB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-20
- Date received
- 2026-03-13
- Regulation
- 878.4962
- Classification name
- Table Mounted Miniaturized Electromechanical Surgical System
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Florence Beck
- Address
- 1501 Old Cheney Rd. Lincoln NE US 68512 68512
FDA Registration Numbers#
- 1450662
- 3030285773
- 3014967969
Source Documents#
Other 510(k) Records For Product Code SAB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN230025 | MIRA Surgical System | Virtual Incision | 2024-02-23 |