← Product Code [FAD](/submissions/GU/subpart-e%E2%80%94surgical-devices/FAD) · K905289

# SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT (K905289)

_Medical Engineering Corp. · FAD · Mar 13, 1991 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAD/K905289

## Device Facts

- **Applicant:** Medical Engineering Corp.
- **Product Code:** [FAD](/submissions/GU/subpart-e%E2%80%94surgical-devices/FAD.md)
- **Decision Date:** Mar 13, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.4620
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAD/K905289](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAD/K905289)

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