510(k) clearance
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
Intuitive Surgical, Inc. · 22 Nov 2022 · K223080
- Decision
- Cleared: the FDA found it substantially equivalent to a device already on the market
- Decision date
- 22 Nov 2022
- Application received
- 30 Sept 2022
- 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.