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510(k) Data Aggregation
K Number
K131303Device Name
DISPOSABLE CIRCULAR STAPLER
Date Cleared
2013-06-11
(35 days)
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
CHANGZHOU CITY ZHIYE MEDICAL DEVICES INSTITUTE CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Circular Stapler has application throughout the alimentary tract for end to-end, end-to-side and side-to-side anastomoses.
Device Description
The disposable circular stapler is preloaded with two staggered rows of 26mm titanium staples in both inner and outer circles. After the deploying of the instrument, the circular knife blade inside the instrument can cut off excess tissue automatically to create a circular anastomosis. The instrument is fired by squeezing the trigger handle firmly as far as it will go. The size of the anastomosis site is determined by the diameter of the selected circular knife blade.
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