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The Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

The proposed Wallflex Enteral Stent with Anchor Lock Delivery System consists of 2 components: an implantable metal stent and a delivery system. The proposed stent is manufactured of Nitinol and offered in two diameters, a 25mm body with a 30mm flare, and a 22mm body with a 27mm flare. Each diameter is offered in three lengths, 6cm, 9cm, and 12cm. The proposed Anchor Lock delivery system consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released by retracting the exterior tube.

The provided text describes a 510(k) summary for the Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System. It states that this is a request for an expanded indication for a device that already has existing market clearance and introduces "no new materials or design changes."

Therefore, the performance data presented in the original K042065 submission was not repeated for this K061877 submission. This means that the current document does not contain the acceptance criteria or the study that proves the device meets those criteria for the expanded indication. Instead, it relies on the predicate device's prior approval.

As such, I cannot fill in the requested table and information based solely on the provided text. The document explicitly states:

"As this is a request for an expanded indication and introduces no new materials or design changes the performance testing presented in K042065 was not repeated."

To answer the prompt fully, one would need to refer to the original K042065 submission, which is not provided here.

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