← Product Code [EZN](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZN) · K884711

# URETHRAL AND URETERAL BALLOON DILATATORS (K884711)

_Primrose Medical, Inc. · EZN · Sep 29, 1989 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZN/K884711

## Device Facts

- **Applicant:** Primrose Medical, Inc.
- **Product Code:** [EZN](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZN.md)
- **Decision Date:** Sep 29, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5470
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZN/K884711](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZN/K884711)

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