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The pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent is used to facilitate drainage from the kidney to the bladder and stenting of the ureter in patients not less than 2 years old. The Stent may be placed using endoscopic, percutaneous or open surgical techniques. The Stent should not be implanted for more than 30 days. This product is not intended as a permanent indwelling device.

The pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent meets the statutory definition of 21 CFR 876.4620 as a "tube-like", implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. Ureteral stents may have finger-like protrusions or hooked ends to keep the tube in place. They are used in the treatment of ureteral injuries and ureteral obstruction. The purpose of this Special 510(k) is to expand the product line of the pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent [510(k) K163068], to add variations in anchorage profile. The recommended usage of the pAguaMedicina™ PERSISTENTTM Structural Hydrogel Ureteral Stent, to facilitate drainage from the kidney to the bladder and stenting of the ureter in patients not less than 2 years old, remains unchanged. Particular uses and the choice of anchorage profile are left to the physician's discretion and suggestions do not appear in the labeling. The labeling will only identify the type of anchorage profile. All stents are radiopaque. All stents by Q Urological TM Corporation are single use, sterile devices, administrated in healthcare facilities by prescription. As with the cleared / predicate pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent, the modified stent may be placed using endoscopic, percutaneous, or open surgical techniques. The stent should not be implanted for more than 30 days. The product is not intended as a permanent indwelling device. The proposed stents will be made of the same material as the predicate (trademark paguamedicina™), a partiality hydrolyzed polyacrylonitrile, produced in part from a proprietary manufacturing process. The modified device incorporates a wire form which creates a pigtail configuration upon deployment. The wire is composed of metals that have been implanted in the human body in a wide variety of locations (tissue and bone), for numerous applications and are considered to be biocompatible. The manufacturing methods, process parameters, design controls and quality assurance system (QSR - 21 CFR 820) used for all pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stents are the same as those of the cleared / predicate device; [510(k) K163068]. The stents are sterilized by E Beam radiation to a sterility assurance level of 10-6.

The pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent is used to facilitate drainage from the kidney to the bladder and stenting of the ureter in patients not less than 2 years old. The Stent may be placed using endoscopes, percutaneous, or open surgical techniques. The Stent should not be implanted for more than 30 days. This product is not intended as a permanent indwelling device.

The pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent is a "fube-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" (21 CFR 876.4620).

pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent is used to facilitate temporary internal urinary drainage from is kidney to the bladder and stenting of the ureter in a pediatric patient no less than 2 years old and not more than 12 years old. The stent may be placed endoscopically, percutaneously, or using open surgical techniques. The stent should not be implanted for more than 30 days. This product is not intended as a permanent indwelling device.

The Q Urological Corporation pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent is substantially equivalent to several predicate devices including: the Sof-Fiex Pediatic Double Pigtail Ureteral Stent (Cook Urological), the Sillouette Pediatric Ureteral Stem (Applied Medical Resource), the PANAMEX Ureteral Stent (Kingston Technologies) and the Aquasilque Ureteral Stent (American Medical Systems). Differences between the predicates and the pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent are the profile of the anchorage and the stent material. The anchorage section of the stent Urological Corporation is radiopaque. The composition of the stent material has been used before in predicate devices. For the pAguaMedicina Structural Hydrogel Pediaric Ureteral Stent this material has been processed by a proprietary method which delivers equivalent technological characteristics.