LUMENDI RECEIVES 510(k) CLEARANCE FOR DILUMEN Ik ... | 合法醫療器材資訊網
ByLumendiAugust20,2019NoComments...TheDiLumenIkknifeispartofagrowingplatformofaccessoriesthatworkinconjunctionwiththe...Ig™EndolumenalInterventionalGrasper,aflexibleendoscopictoolintendedtograspand...Is™Endolumenal
1000 Therapeutic Procedures Using DiLumen™ EIP Completed Across U.S., Europe and AsiaWESTPORT, CONN, August 20, 2019 − Connecticut-based medical device innovator Lumendi, LLC (http://www.lumendi.com[1]) has announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the DiLumen Ik™ Endolumenal Interventional Knife, a sterile, single-use, disposable monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. The DiLumen Ik™ is also designed to deliver a seamless submucosal injection to create and maintain a fluid cushion during tissue dissection. This is the seventh device Lumendi has developed as the company continues to advance minimally invasive endolumenal therapies.
Lumendi also reports that, to date, clinicians in the U.S., several EU countries including Germany, France, ...
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LUMENDI RECEIVES 510(k) CLEARANCE FOR DILUMEN Ik ... | 合法醫療器材資訊網
LUMENDI RECEIVES FDA 510(k) CLEARANCE FOR ... | 合法醫療器材資訊網
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【"羅曼迪" 內視鏡附件 (未滅菌)】許可證字號:衛部醫器輸壹字第021931號
器材品名:"羅曼迪"內視鏡附件(未滅菌)許可證字號:衛部醫器輸壹字第021931號註銷狀態:註銷日期:註銷理由:有效日期:2025/09/04...