FDA-Device2020-04-22Class II
Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds
Boddingtons Plastics Ltd
Hazard
Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)
Sold states
Nationwide Foreign:
Affected count
13202 Units US
Manufactured in
Wheelbarrow Park Estate, Pattenden Lane, Tonbridge, United Kingdom
Products
Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1718-2020Don't want to check this manually?
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