# DEN230025 (us_fda)

FDA De Novo DEN230025 for Virtual Incision MIRA Surgical System. First miniaturized robotic-assisted surgery device. For colectomy procedures.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_de_novo
- Status: cleared
- Filing number: DEN230025
- Filing date: 2024-02-23
- Decision date: 2024-02-23
- Verification posture: verified
- Cap-flag notes: First miniRAS device. IDE clinical study completed.

## Applicant

- [Virtual Incision](/companies/virtual-incision.md)

## Covered models (1)

- [MIRA](/models/virtual-incision-mira.md)

## Sources (1)

- [https://www.accessdata.fda.gov/cdrh_docs/pdf23/DEN230025.pdf](https://www.accessdata.fda.gov/cdrh_docs/pdf23/DEN230025.pdf)

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