510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QGXClass I

General Use Pneumatic Tourniquet

21 CFR 878.5910 / General, Plastic Surgery
FDA source (opens on fda.gov)

QGX is the FDA product code for General Use Pneumatic Tourniquet, a class I device type, regulated under 21 CFR 878.5910. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QGX
Device name
General Use Pneumatic Tourniquet
FDA 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.
Regulation
21 CFR 878.5910
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order