510(k) clearance
MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
Hansen Medical, Inc. · 27 Sept 2013 · K132369
- Decision
- Cleared: the FDA found it substantially equivalent to a device already on the market
- Decision date
- 27 Sept 2013
- Application received
- 30 July 2013
- Company
- Hansen Medical, Inc.
- Device type
- Product code (DXX)
What it means
A 510(k) clearance means the FDA agreed the device is as safe and effective as one already on the market, so it may be sold in the US. It is not an approval and not a finding that it works better than surgery without a robot. See FDA clearance, explained.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.