Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
The Piston Syringe With Neuraxial Connector is intended to inject or withdraw fluid from the neuraxial space using neuraxial-specific connections compliant with ANSI/AAMI/ISO 80369-6:2016, covering epidural, peripheral, subarachnoid/spinal, intrathecal, and/or intracerebroventricular administration routes. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 880.5860 in the General Hospital specialty. The product code is QEH. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QEH
- Device Class
- FDA class 2
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code may include epidural, peripheral, subarachnoid/spinal block, intrathecal and/or intracerebroventricular administration routes. The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241385 | Omnifix Syringe NRFit | Jul 13, 2024 | Substantially Equivalent | B.Braun Medical, Inc. |
| K213800 | Artiglass NRFitTM Tip L.O.R. Glass Syringes | May 19, 2022 | Substantially Equivalent | Artiglass Srl |
| K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | Dec 16, 2020 | Substantially Equivalent | International Medical Industries, Inc. |
| K192538 | BD Syringe NRFit Lok and BD Syringe NRFit Slip | Sep 04, 2020 | Substantially Equivalent | Becton, Dickinson and Company |
| K181374 | NRFit Syringe | Dec 14, 2018 | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.