General Use Pneumatic Tourniquet

QGX · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.5910

Classification

FDA Product Code: QGX
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 878.5910
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 12

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown