(136 days)
The UroSurge UroStent™ is intended to 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 open surgical techniques. The duration of the placement of these stents must not remain indwelling more than twenty nine (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.
Not Found
The provided documents do not contain information about acceptance criteria or a study that proves the UroSurge UroStent™ meets acceptance criteria. The documents are a 510(k) clearance letter from the FDA and an Indications For Use Statement. They confirm the device's substantial equivalence to previously marketed devices and define its intended use, but they do not describe performance metrics, study designs, or data analysis related to specific acceptance criteria.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).