SURGITEK NEPHROSTENT KIT
Device Facts
| Record ID | K831446 |
|---|---|
| Device Name | SURGITEK NEPHROSTENT KIT |
| Applicant | Mec/Surgitek Products |
| Product Code | FAD · Gastroenterology, Urology |
| Decision Date | Jun 22, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4620 |
| Device Class | Class 2 |
Regulatory Classification
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.
