QEH · Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
General Hospital · 21 CFR 880.5860 · Class 2
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 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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 | Omnifix Syringe NRFit | B.Braun Medical, Inc. | Jul 13, 2024 | SESE |
| K213800 | Artiglass NRFitTM Tip L.O.R. Glass Syringes | Artiglass Srl | May 19, 2022 | SESE |
| K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | International Medical Industries, Inc. | Dec 16, 2020 | SESE |
| K192538 | BD Syringe NRFit Lok and BD Syringe NRFit Slip | Becton, Dickinson and Company | Sep 4, 2020 | SESE |
| K181374 | 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
