Regulatory filing

fda_de_novo (us_fda)

Galen Robotics receives FDA De Novo Grant for Galen Surgical Robot after five years of development.

fda de novo · cleared · decided 2026-01-01

Track fda_de_novo (us_fda)

Machine-readable surfaces

Markdown mirror: /regulatory-filings/galen-robotics-fda-de-novo.md
JSON-LD: embedded in this page’s head
REST API: /v1/filings/c1662e12-8c9c-4eb3-80e2-a1c70409d8e4
Revision history: /regulatory-filings/galen-robotics-fda-de-novo/history
Data documentation: /data
Query this programmatically: Deploy MCP

Key facts

Jurisdiction: us_fda
Filing type: fda de novo
Status: cleared
Decision date: 2026-01-01

Covered models (1)

Galen Surgical Robot

Sources (1)

https://i95business.com/articles/content/galen-robotics-celebrates-fda-de-novo-clearance-reflects-on-the-journey-2140

Deploy Watch

Track fda_de_novo (us_fda).

We notify you when the filing status changes or related filings, incidents, or litigations surface.

Identity

c1662e12-8c9c-4eb3-80e2-a1c70409d8e4