Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4680](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4680) → ONJ — Dissolvable Gel For Preventing Ureteral Stone Migration

# ONJ · Dissolvable Gel For Preventing Ureteral Stone Migration

_Gastroenterology, Urology · 21 CFR 876.4680 · Class 2_

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

## Overview

- **Product Code:** ONJ
- **Device Name:** Dissolvable Gel For Preventing Ureteral Stone Migration
- **Regulation:** [21 CFR 876.4680](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4680)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K090430](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/ONJ/K090430.md) | BACKSTOP AND BACKSTOP INJECTOR | Pluromed, Inc. | Jun 2, 2009 | SESE |

## Top Applicants

- Pluromed, Inc. — 1 clearance

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

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