QGX · General Use Pneumatic Tourniquet
General, Plastic Surgery · 21 CFR 878.5910 · Class 1
Overview
| Product Code | QGX |
|---|---|
| Device Name | General Use Pneumatic Tourniquet |
| Regulation | 21 CFR 878.5910 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
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 during surgery.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
