21 CFR 878.5910 — Tourniquet, Pneumatic

General, Plastic Surgery (SU) · Part 878 Subpart F—Therapeutic Devices · § 878.5910

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KCYTourniquet, Pneumatic134
QGXGeneral Use Pneumatic Tourniquet10
Innolitics

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