QEH
5 FDA 510(k) clearances · Product code
204 daysmedian time to decision
354 days90th percentile
5clearances measured
FDA profile
- Official device name
- Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Medical specialty
- General Hospital
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Omnifix Syringe NRFit (K241385) | B.Braun Medical, Inc. | 2024-07-13 |
| Artiglass NRFitTM Tip L.O.R. Glass Syringes (K213800) | Artiglass Srl | 2022-05-19 |
| NRFit® Caps, Male and Female Neuraxial Tip Caps (K201031) | International Medical Industries, Inc. | 2020-12-16 |
| BD Syringe NRFit Lok and BD Syringe NRFit Slip (K192538) | Becton, Dickinson and Company | 2020-09-04 |
| NRFit Syringe (K181374) | Jiangsu Caina Medical Co.,Ltd | 2018-12-14 |
Track QEH automatically
Every clearance here is in the API, with alerts when new ones post.