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NXT Tissue HeliX Pro
Intragastric Balloon System
Details
Device typeSuturing unit, single-use: A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.
FDA categoryEndoscopic suturing device for altering gastric anatomy for weight loss, Endoscopic tissue approximation device
Device ID00191506060060
Catalog numberM00505490
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information