← Product Code [FGF](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGF) · K903994

# URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION (K903994)

_Applied Urology, Inc. · FGF · Oct 19, 1990 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGF/K903994

## Device Facts

- **Applicant:** Applied Urology, Inc.
- **Product Code:** [FGF](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGF.md)
- **Decision Date:** Oct 19, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5130
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGF/K903994](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FGF/K903994)

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