510(k) clearance
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000
Intuitive Surgical, Inc. · 8 April 2011 · K101581
- Decision
- Cleared: the FDA found it substantially equivalent to a device already on the market
- Decision date
- 8 April 2011
- Application received
- 7 June 2010
- 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.