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The UroSurge SpiraFlo Ureteral Stent has no holes in the walls along the side of the stent. This is in addition to the fact that it will be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or even surgical techniques. These stents must not remain indwelling for more than 29 days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.

The UroSurge SpiraFlo Ureteral Stent has no holes in the walls along the side of the stent. This is in addition to the fact that it will be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or even surgical techniques. These stents must not remain indwelling for more than 29 days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the UroSurge SpiraFlo Ureteral Stent, primarily outlining its substantial equivalence to a predicate device and its indications for use. It does not detail specific acceptance criteria, study methodologies, or performance results.

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