Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5290](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5290) → QGD — Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories

# QGD · Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories

_Gastroenterology, Urology · 21 CFR 876.5290 · Class 1_

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

## Overview

- **Product Code:** QGD
- **Device Name:** Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories
- **Regulation:** [21 CFR 876.5290](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5290)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

Implanted mechanical/hydraulic urinary continence device surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of an implanted mechanical/hydraulic urinary continence device. This generic type of device includes the measurement tool or tape, connector assembly tool, tubing plug, incision closing tool, tubing passer, blunt needle, and hemostat shod tubing.

## 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/QGD](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/QGD)

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