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) → GAX — Tourniquet, Nonpneumatic

# GAX · Tourniquet, Nonpneumatic

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

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

## Overview

- **Product Code:** GAX
- **Device Name:** Tourniquet, Nonpneumatic
- **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 (20 of 20)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K931198](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K931198.md) | UNIQUET | Icat Systems | Sep 1, 1993 | SESE |
| [K881398](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K881398.md) | TOURNIQUET | Barretta Products, Research and Development, Inc. | Apr 29, 1988 | SESE |
| [K881176](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K881176.md) | STERILE ESMARCH BANDAGE | Spectrum/Hydro-Med Products, Inc. | Apr 11, 1988 | SESE |
| [K875092](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K875092.md) | DEGANIA SILICONE TOURNIQUET | Degania Silicone , Ltd. | Jan 7, 1988 | SESE |
| [K873928](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K873928.md) | UNIVERSAL TOURNIQUET | Dryden Corp. | Oct 23, 1987 | SESE |
| [K872003](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K872003.md) | KINDERWRAP | The Kinder Co. | Jun 23, 1987 | SESE |
| [K864897](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K864897.md) | DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 | Dale Medical Products, Inc. | Jan 12, 1987 | SESE |
| [K853472](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K853472.md) | FINGER TOURNIQUETTE | Joseph B. Marogil | Oct 10, 1985 | SESE |
| [K853537](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K853537.md) | VELCRO TOURNIQUET | Cp Medical | Sep 12, 1985 | SESE |
| [K852277](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K852277.md) | CATAPRESS TOURNIGUET | Boehringer Ingelheim Pharmaceuticals, Inc. | Jun 27, 1985 | SESE |
| [K851482](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K851482.md) | TOURNIQUET | Polymer Technology Corp. | Apr 29, 1985 | SESE |
| [K843056](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K843056.md) | ELASTIC BANDAGE | Sterile Medical Systems | Dec 4, 1984 | SESE |
| [K840489](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K840489.md) | DISPOSIQUET A DISPOS. TOURNIQUET | Med Lab Products | Mar 12, 1984 | SESE |
| [K830467](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K830467.md) | TOURNIQUET/LATEX TOURNIQUET | Primeline Industries, Inc. | Mar 31, 1983 | SESE |
| [K822553](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K822553.md) | PRESSURE-QUET TOURNIQUET | Nutec Med, Inc. | Sep 17, 1982 | SESE |
| [K821700](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K821700.md) | LATEX PENROSE DRAIN TUBING | Abco Dealers, Inc. | Jun 16, 1982 | SESE |
| [K803142](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K803142.md) | CONPHAR VELCRO TOUNIGUER | Conphar, Inc. | Jan 13, 1981 | SESE |
| [K790802](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K790802.md) | ESSAR TOURNIQUET FOR VENIPUNCTURE | Stewart Research, Inc. | May 1, 1979 | SESE |
| [K780594](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K780594.md) | VELKET TOURNIQUET | Abco Dealers, Inc. | Jun 6, 1978 | SESE |
| [K780429](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/GAX/K780429.md) | TOURNEQUET, NON-PNEUMATIC | Hemox, Inc. | Apr 18, 1978 | SESE |

## Top Applicants

- Abco Dealers, Inc. — 2 clearances
- Barretta Products, Research and Development, Inc. — 1 clearance
- Boehringer Ingelheim Pharmaceuticals, Inc. — 1 clearance
- Conphar, Inc. — 1 clearance
- Cp Medical — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com