FDA-Device2016-08-17Class II
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
Halyard Health, Inc
Hazard
Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
Sold states
Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.
Affected count
51 kits
Manufactured in
5405 Windward Pkwy, Alpharetta, GA, United States
Products
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2391-2016Don't want to check this manually?
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