Code of Federal Regulations Title 21. Food and Drugs § 21.876.4620 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).