Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5100](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5100) → QGC — Suprapubic Catheter Accessories

# QGC · Suprapubic Catheter Accessories

_Gastroenterology, Urology · 21 CFR 876.5100 · Class 1_

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

## Overview

- **Product Code:** QGC
- **Device Name:** Suprapubic Catheter Accessories
- **Regulation:** [21 CFR 876.5100](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5100)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath.

## 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._

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

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