EYR · Tourniquet, Gastro-Urology
General, Plastic Surgery · 21 CFR 878.5900 · Class 1
Overview
| Product Code | EYR |
|---|---|
| Device Name | Tourniquet, Gastro-Urology |
| 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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K802850 | TECNOL O.R. TOURNIQUET COVER | Tecnol New Jersey Wound Care, Inc. | Jan 13, 1981 | SESE |
| K792256 | KEITHLEY CLAMP | Keithley Development Co. | Dec 6, 1979 | SESE |
Top Applicants
- Tecnol New Jersey Wound Care, Inc. — 1 clearance
- Keithley Development Co. — 1 clearance
