endoscopy solution News
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Mauna Kea Technologies Receives FDA Clearance and CE Marking For Its Next-Generation Cellvizio® Platform
The new Cellvizio®platform includes significant improvements and will enable major innovations Mauna Kea Technologies announced today that it has obtained 510(k) clearance (K193416) from the U.S. Food and Drug Administration (FDA) and CE marking of the next-generation Cellvizio® endomicroscopy platform, built with the company’s new proprietary system architecture. This marks the ...
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EndoClot Plus, Inc. Announces FDA Clearance of GI Submucosal Lifting Product
EndoClot Plus, Inc. (EPI), a privately held medical device company announced the FDA 510(k) clearance of EndoClot® Submucosal Injection Agent (EndoClot® SIA) manufactured by EndoClot Plus Co., Ltd. located in Suzhou, China. This product is expected to be commercially available in the United States beginning in May 2020 and later this year in several international markets. EndoClot® ...
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EndoClot Expands GI Hemostasis Portfolio With Launch of EndoClot® Adhesive
EndoClot Plus, Inc., a privately held medical device company founded by surgeons and biomaterial scientists announces the CE approval of EndoClot® Adhesive manufactured by EndoClot Plus Co., Ltd. located in Suzhou, China. The product will be made available for discussion during the upcoming Digestive Disease Week held in Washington DC, June 2-5, 2018. EndoClot® Adhesive is a single-use ...
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