FDA-Device2013-06-05Class II
Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.
Intuitive Surgical, Inc.
Hazard
Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
Sold states
USA Nationwide distribution
Affected count
2,423 consignee
Manufactured in
1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, United States
Products
Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1426-2013Don't want to check this manually?
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