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510(k) Data Aggregation
K Number
K201744Device Name
Su2ura Approximation Device
Manufacturer
Anchora Medical, Ltd.
Date Cleared
2021-06-17
(357 days)
Product Code
OCW
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Anchora Medical, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Su2ura® Approximation Device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue.
Device Description
The Anchora Su2ura® Approximation Device is a sterile single use device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue. The device is a 5mm single-use endoscopic suturing device loaded with threaded anchors. It is designed to deploy up to 19 anchors by a trigger action of the handle of the delivery system. After deployment, each anchor is anchored within the tissue in which it was deployed. After deployment of 2 or more anchors, the suture that passes between the anchors can be tightened to pull the anchors toward each other and approximate the tissue. The delivery system consists of a plastic handle and a 36-cm stainless steel shaft. The handle includes a Trigger, a Knob, and a Toggle Button. A Cap can be added at the distal edge of the Shaft to advance extracorporeal suture knots. The anchors can be deployed in single-stitch or running- stitch configuration. The device deploys the anchors through a needle with an outer diameter of 2.1 mm, available in two lengths: 5 mm and 9 mm protrusion. The Anchor is advanced outside of the needle by a Pushrod. Each anchor, made of stainless steel, is threaded with an off-the-shelf UHMWPE suture manufactured by Teleflex Medical. The device provides the anchors already threaded on this suture. The device is sterile packaged and designed for single use only. The device is manufactured from medical grade materials (mainly plastics and stainless steels).
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