Regulatory filing

fda_510k (us_fda)

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

fda 510k · cleared · decided 2018-01-01

Track fda_510k (us_fda)

Machine-readable surfaces

Markdown mirror: /regulatory-filings/auris-monarch-fda-510k.md
JSON-LD: embedded in this page’s head
REST API: /v1/filings/6b166e72-1d20-4f9c-b85f-5c3542df97b5
Revision history: /regulatory-filings/auris-monarch-fda-510k/history
Data documentation: /data
Query this programmatically: Deploy MCP

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

Covered models (1)

Monarch Platform

Sources (1)

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

Deploy Watch

Track fda_510k (us_fda).

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

Identity

6b166e72-1d20-4f9c-b85f-5c3542df97b5