FDA-Device2020-05-27Class II
CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
Capso Vision, Inc.
Hazard
Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
Sold states
US Nationwide distribution including in the states of FL, GA, NY, PA, and TX.
Affected count
44 units
Manufactured in
18805 Cox Ave Ste 250, N/A, Saratoga, CA, United States
Products
CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2073-2020Don't want to check this manually?
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