QEH — Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact Class II
Classification Details
- Product Code
- QEH
- Device Class
- Class II
- Regulation Number
- 880.5860
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241385 | b.braun medical | Omnifix Syringe NRFit | July 13, 2024 |
| K213800 | artiglass | Artiglass NRFitTM Tip L.O.R. Glass Syringes | May 19, 2022 |
| K201031 | international medical industries | NRFit® Caps, Male and Female Neuraxial Tip Caps | December 16, 2020 |
| K192538 | becton, dickinson and | BD Syringe NRFit Lok and BD Syringe NRFit Slip | September 4, 2020 |
| K181374 | jiangsu caina medical co | NRFit Syringe | December 14, 2018 |