General Use Pneumatic Tourniquet
The General Use Pneumatic Tourniquet is an air-powered surgical device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff, with the cuff wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgical procedures. It is classified as FDA Class 1, with no premarket notification required (GMP exempt not indicated, but exempt from 510(k)), under regulation 878.5910 in the General and Plastic Surgery specialty. The product code is QGX. It is not an implant and is not life-sustaining.
Research product code QGX in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- QGX
- Device Class
- FDA class 1
- Regulation Number
- 878.5910
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.