FDA-Device2019-03-20Class II
US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
US Endoscopy Group Inc
Hazard
Potential esophageal laceration during a patient procedure
Sold states
Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Czech Republic, Germany, Great Britain, India, Italy, Lebanon, Mexico, Netherlands, Norway, Philippines, S. Korea, Spain, Sweden and United Arab Emirates.
Affected count
483 units ( 325 units US and 158 OUS)
Manufactured in
5976 Heisley Rd, N/A, Mentor, OH, United States
Products
US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1011-2019Don't want to check this manually?
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