SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT
Device Facts
| Record ID | K905289 |
|---|---|
| Device Name | SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT |
| Applicant | Medical Engineering Corp. |
| Product Code | FAD · Gastroenterology, Urology |
| Decision Date | Mar 13, 1991 |
| 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.
