FDA-Device2019-07-17Class II
E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.
Richard Wolf Medical Instruments Corp.
Hazard
E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
Sold states
US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri.
Affected count
5 boxes (5 electrodes each)
Manufactured in
353 Corporate Woods Pkwy, Vernon Hills, IL, United States
Products
E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1957-2019Don't want to check this manually?
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