Product code QGX

Device name

General Use Pneumatic Tourniquet

Medical specialty

General, Plastic Surgery

Device class

1

Regulation number

878.5910

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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.

Source

FDA openFDA device classification dataset