Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4630](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4630) → QGB — Ureteral Stent Accessories

# QGB · Ureteral Stent Accessories

_Gastroenterology, Urology · 21 CFR 876.4630 · Class 1_

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

## Overview

- **Product Code:** QGB
- **Device Name:** Ureteral Stent Accessories
- **Regulation:** [21 CFR 876.4630](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4630)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

Ureteral stent accessories aid in the insertion of the ureteral stent that is placed into the ureter to provide ureteral rigidity and allow the passage of urine. This generic type of device includes the stent positioner, wire guide, and pigtail straightener.

## Classification Rationale

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

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com