Amsel Medical Corporation Announces Filing of 2nd 510(k) Pre-Marketing Notification with the US Food and Drug Administration for the Amsel Occluder Device

The Amsel Occluder Device is intended for use in open general surgery procedures on tubular structures or blood vessels (arteries and veins) wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm

CAMBRIDGE, Mass.,  Amsel Medical Corporation today announced that it has successfully completed filing of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Amsel Occluder Device extending the indications of the Amsel Occluder Device to include a percutaneous route of administration. The company is seeking the following indications statement: “The Amsel Occluder Device is intended for use in open general surgery procedures or in percutaneous procedures when clinically indicated, on tubular structures or blood vessels (arteries and veins) wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm.”

Uri Rimon, Director of Interventional Radiology, Sheba Medical Center, Tel Hashomer Hospital, Israel, commented, "The precision and control for vessel closure afforded by the Amsel Vessel Occluder represents a fresh approach to facilitating accurate, complete and secure vessel closure. The Amsel Occluder Device provides a secure method for transfixing a tubular structure, such as a blood vessel. I look forward to the clinical use of the Amsel Vessel Occluder once it receives FDA pre-market clearance."

Arnold Miller, MD, Founder and President of Amsel Medical Corporation commented, “We are thrilled to expand the Amsel portfolio of occlusion technologies with the filing of our second Pre-Marketing Notification (510(k)) with FDA. We anticipate significant clinical interest for this innovative technology in the markets where the Amsel Occluder Device will be cleared for commercial distribution. This is the second in a series of regulatory filings, while we continue the development of several additional Amsel Occluder products.”

Source: BusinessWire