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Amsel Medical said today that its Amsel Endo occluder device has received FDA 510(k) approval, which is used to seal blood vessels during endoscopic surgery.
The Cambridge, Massachusetts-based company touts that so far, the company's occluder device portfolio has received FDA approval for the third time.
The Amsel Endo occluder is a mechanical occluder clip that is delivered through a fine needle and is designed to be deployed to fix the target vessel while clamping it. The device consists of an endoscopic suit clip applier and clips, which the company says are intended or used for tubular structures or blood vessels.
"We are very pleased to expand the Amsel occluder series of disposable, site-specific vascular control devices to the endoscopic and minimally invasive surgery markets through the pre-market notice (510(k)) recently issued by the US Food and Drug Administration. Amsel The occluder has the ability to penetrate and ligate selected blood vessels or catheters. We expect that this innovative technology will generate significant clinical interest in the market where Amsel occluder devices are approved for commercial distribution," said founder and prez Arnold · Dr. Miller said in a press release.
In November last year, Amsel Medical touted the first human clinical use of its Amsel AOD2 occluder device, which was performed at the New York University Langone Medical Center in New York.
The submission is as follows: 510(k), features, regulatory/compliance, vascular label: amselmedical
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