21 CFR 876.4620 — Stent, Ureteral
Gastroenterology, Urology (GU) · Subpart E—Surgical Devices · § 876.4620
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FAD | Stent, Ureteral | 2 | 122 | 3rd Party, Implant |
