510(k) clearance
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
Intuitive Surgical, Inc. · 18 Feb 2009 · K081137
- Decision
- Cleared: the FDA found it substantially equivalent to a device already on the market
- Decision date
- 18 Feb 2009
- Application received
- 21 April 2008
- 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.