NRFit Syringe
FDA 510(k) K181374 · Jiangsu Caina Medical Co.,Ltd
Submission
- Device name
- NRFit Syringe
- Applicant
- Jiangsu Caina Medical Co.,Ltd
Jiangyin, CN - Received
- May 24, 2018
- Decision date
- December 14, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEH – 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
- Specialty
- General Hospital
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…
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241385 | Omnifix Syringe NRFitQEH · Traditional | B.Braun Medical, Inc. | 07/13/2024SE |
| K213800 | Artiglass NRFitTM Tip L.O.R. Glass SyringesQEH · Special | Artiglass Srl | 05/19/2022SE |
| K201031 | NRFit® Caps, Male and Female Neuraxial Tip CapsQEH · Traditional | International Medical Industries, Inc. | 12/16/2020SE |
| K192538 | BD Syringe NRFit Lok and BD Syringe NRFit SlipQEH · Traditional | Becton, Dickinson and Company | 09/04/2020SE |
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Questions and answers
When was NRFit Syringe cleared by the FDA?
NRFit Syringe (K181374) received a 510(k) decision of Substantially Equivalent on December 14, 2018, 204 days after the submission was received.
What is the product code of K181374?
The FDA product code is QEH – Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact , a Class II (moderate risk) device regulated under 21 CFR 880.5860.