MIRA Surgical System
FDA 510(k) clearance DEN230025 · decided 2024-02-23
Clearance details
- K-number
- DEN230025
- Device name
- MIRA Surgical System
- Applicant
- Virtual Incision
- Decision
- Unknown
- Date received
- 2023-04-11
- Decision date
- 2024-02-23
- Days to decision
- 318 days
- Clearance type
- Direct
- Product code
- SAB
- Device class
- 2
- Regulation number
- 878.4962
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lincoln, NE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.