FDA-Device2020-07-29Class II
Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.
Medtronic Sofamor Danek USA Inc
Hazard
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.
Affected count
25 pk
Manufactured in
1800 Pyramid Pl, N/A, Memphis, TN, United States
Products
Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2695-2020Don't want to check this manually?
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