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This catheter/stent is intended for use when the physician selects a patient suitable for percutaneous drainage from the ureterpelvic junction to the bladder while maintaining external access.

Modified Uresil® Nephro-Ureteral Stent

This document is a 510(k) clearance letter from the FDA for a medical device called the "Uresil® Nephro-Ureteral Stent" (K980889). It declares the device substantially equivalent to pre-amendment devices or reclassified devices.

This type of document (510(k) clearance) does not include information about specific acceptance criteria or studies proving device performance in the way a clinical trial report or a performance study summary for an AI/ML powered device would.

The FDA 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on proving novel performance metrics or conducting extensive new clinical studies unless the device represents a significant technological change.

Therefore, I cannot provide the requested information from this document. The document primarily discusses regulatory classification and marketing authorization based on substantial equivalence.

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