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510(k) Data Aggregation
(220 days)
The device is indicated to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions in the ureter. The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic techniques. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent indwelling device.
The subject devices are coated ureteral stent that are supplied as a standalone product (including a pigtail straightener) or as part of a set, available in two configurations:
- Basic Set: Includes a ureteral stent, pigtail straightener, and positioner.
- Full Set: Includes a ureteral stent, pigtail straightener, positioner, and J-tip guide wire.
The coated stents are flexible tubular devices made of radiopaque polyurethane, featuring self-retaining coiled pigtail structures at both ends. The stent body incorporates multiple drainage holes to ensure smooth urine flow from the renal pelvis to the bladder. The dual-pigtail design positions the proximal end in the renal pelvis and the distal end in the bladder. Additionally, the stent surface is marked with graduated scales for precise intraoperative positioning.
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