510(k) clearance
da Vinci Xi 12 8 mm Reducer
Intuitive Surgical, Inc. · 21 Sept 2016 · K162411
- Decision
- Cleared: the FDA found it substantially equivalent to a device already on the market
- Decision date
- 21 Sept 2016
- Application received
- 29 Aug 2016
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
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.