# fda_510k (us_fda)

FDA 510(k) clearance for Auris Health Monarch surgical robot. Second FDA clearance for urology indication.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_510k
- Status: cleared
- Filing date: 2018-01-01
- Decision date: 2018-01-01
- Verification posture: verified

## Applicant

- [Auris Health](/companies/auris-health.md)

## Covered models (1)

- [Monarch Platform](/models/auris-health-monarch.md)

## Sources (1)

- [https://www.fiercebiotech.com/medtech/fda-crowns-monarch-surgical-robot-jjs-auris-health-urology-nod](https://www.fiercebiotech.com/medtech/fda-crowns-monarch-surgical-robot-jjs-auris-health-urology-nod)

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