Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5860](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5860) → QEH — Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact

# QEH · Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact  

_General Hospital · 21 CFR 880.5860 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QEH

## Overview

- **Product Code:** QEH
- **Device Name:** Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact  
- **Regulation:** [21 CFR 880.5860](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5860)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K241385](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QEH/K241385.md) | Omnifix Syringe NRFit | B.Braun Medical, Inc. | Jul 13, 2024 | SESE |
| [K213800](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QEH/K213800.md) | Artiglass NRFitTM Tip L.O.R. Glass Syringes | Artiglass Srl | May 19, 2022 | SESE |
| [K201031](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QEH/K201031.md) | NRFit® Caps, Male and Female Neuraxial Tip Caps | International Medical Industries, Inc. | Dec 16, 2020 | SESE |
| [K192538](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QEH/K192538.md) | BD Syringe NRFit Lok and BD Syringe NRFit Slip | Becton, Dickinson and Company | Sep 4, 2020 | SESE |
| [K181374](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QEH/K181374.md) | NRFit Syringe | Jiangsu Caina Medical Co.,Ltd | Dec 14, 2018 | SESE |

## Top Applicants

- Artiglass Srl — 1 clearance
- B.Braun Medical, Inc. — 1 clearance
- Becton, Dickinson and Company — 1 clearance
- International Medical Industries, Inc. — 1 clearance
- Jiangsu Caina Medical Co.,Ltd — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QEH](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QEH)

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