Regulatory filing

DEN230025 (us_fda)

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

fda de novo · cleared · decided 2024-02-23

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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

Covered models (1)

MIRA

Sources (1)

https://www.accessdata.fda.gov/cdrh_docs/pdf23/DEN230025.pdf

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Identity

1211e1a8-02ab-4c17-b7f8-4ebd6939f482