FDA-Device2020-07-15Class II
The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: 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
Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of diagnosis and the patient may need to repeat the exam.
Sold states
US Nationwide distribution including in the states of AZ, CA, DE, MD, NJ, NY, SC, and VA.
Affected count
82
Manufactured in
18805 Cox Ave Ste 250, Saratoga, CA, United States
Products
The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: 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-2536-2020Don't want to check this manually?
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