FDA 510(k) approval for DiLumen Is Endolumenal Interventional Scissors, a device to support endoscopic procedures.-Lumendi LLC.
Connecticut-based medical device company Lumendi, LLC has announced it has received FDA 510(k) clearance for the DiLumen Is Endolumenal Interventional Scissors, a sterile, single-use, disposable monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. This is the fourth device Lumendi has developed as the company continues to advance minimally invasive endolumenal therapies.
Lumendi�s DiLumen Is and recently 510(k) cleared DiLumen C2 will round out a complete platform of accessories intended to improve access and therapy in the colon and reduce surgical interventions. The DiLumen C2 is a second-generation Endolumenal Interventional Platform (EIP) designed to provide complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment.
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