510(k) DEN230025
- Device
- MIRA Surgical System
- Applicant
- Virtual Incision
- 510(k) number
- DEN230025
- Product code
- SAB
- Decision
- Unknown (DENG)
- Decision date
- 2024-02-23
- Date received
- 2023-04-11
- 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
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Florence Beck
- Address
- 2125 Transformation Dr. Suite 1300 Lincoln NE US 68508 68508
FDA Registration Numbers#
- 3014967969
- 3030285773
Source Documents#
510(k) summary PDF not indicated by FDA