OJS · Tourniquet Kit
General, Plastic Surgery · 21 CFR 878.5900 · Class 1
Overview
| Product Code | OJS |
|---|---|
| Device Name | Tourniquet Kit |
| Regulation | 21 CFR 878.5900 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
