Regulatory filing

K251197 (us_fda)

Distalmotion Dexter robotic surgical system FDA 510(k) clearance K251197. Soft tissue surgical robot with wristed robotics.

fda 510k · cleared · decided 2025-09-30

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing number: K251197
Decision date: 2025-09-30

Covered models (1)

Dexter

Sources (1)

https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251197.pdf

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Identity

1c490325-6334-4aa1-971e-5f12dd55947c