21 CFR 878.5900 — Tourniquet, Gastro-Urology

General, Plastic Surgery (SU) · Part 878 Subpart F—Therapeutic Devices · § 878.5900

Identification

A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tightened to reduce circulation.

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
EYRTourniquet, Gastro-Urology12
GAXTourniquet, Nonpneumatic120
OJSTourniquet Kit10
Innolitics

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