QGX — General Use Pneumatic Tourniquet Class I
FDA product code QGX covers "General Use Pneumatic Tourniquet", a Class I medical device regulated under 21 CFR 878.5910. Submissions are reviewed by the General, Plastic Surgery panel.
Classification Details
- Product Code
- QGX
- Device Class
- Class I
- Regulation Number
- 878.5910
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.