Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart F — Therapeutic Devices](/submissions/SU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 878.5910](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/878.5910) → QGX — General Use Pneumatic Tourniquet

# QGX · General Use Pneumatic Tourniquet

_General, Plastic Surgery · 21 CFR 878.5910 · Class 1_

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

## Overview

- **Product Code:** QGX
- **Device Name:** General Use Pneumatic Tourniquet
- **Regulation:** [21 CFR 878.5910](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/878.5910)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.

## 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 § 878.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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