Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart F — Therapeutic Devices](/submissions/SU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 878.5900](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/878.5900) → EYR — Tourniquet, Gastro-Urology

# EYR · Tourniquet, Gastro-Urology

_General, Plastic Surgery · 21 CFR 878.5900 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/EYR

## Overview

- **Product Code:** EYR
- **Device Name:** Tourniquet, Gastro-Urology
- **Regulation:** [21 CFR 878.5900](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/878.5900)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K802850](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/EYR/K802850.md) | TECNOL O.R. TOURNIQUET COVER | Tecnol New Jersey Wound Care, Inc. | Jan 13, 1981 | SESE |
| [K792256](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/EYR/K792256.md) | KEITHLEY CLAMP | Keithley Development Co. | Dec 6, 1979 | SESE |

## Top Applicants

- Keithley Development Co. — 1 clearance
- Tecnol New Jersey Wound Care, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/EYR](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/EYR)

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