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) → NQT — Dislodger, Stone, Flexible, Ureteral, Reprocessed

# NQT · Dislodger, Stone, Flexible, Ureteral, Reprocessed

_Gastroenterology, Urology · 21 CFR 876.4680 · Class 2_

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

## Overview

- **Product Code:** NQT
- **Device Name:** Dislodger, Stone, Flexible, Ureteral, Reprocessed
- **Regulation:** [21 CFR 876.4680](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4680)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)
- **3rd-party reviewable:** yes

## 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 (0 of 0)

_No cleared devices on record._

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

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