Artiglass NRFitTM Tip L.O.R. Glass Syringes
FDA 510(k) K213800 · Artiglass Srl
Submission
- Device name
- Artiglass NRFitTM Tip L.O.R. Glass Syringes
- Applicant
- Artiglass Srl
Due Carrare, IT - Received
- December 6, 2021
- Decision date
- May 19, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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…
Other 510(k)s with product code QEH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241385 | Omnifix Syringe NRFitQEH · Traditional | B.Braun Medical, Inc. | 07/13/2024SE |
| 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 |
| K181374 | NRFit SyringeQEH · Traditional | Jiangsu Caina Medical Co.,Ltd | 12/14/2018SE |
More from Jiangsu Caina Medical Co.,Ltd
| 510(k) | Device | Decision |
|---|---|---|
| K122416 | Artiglass L. O.R. Glass SyringeFMF · Traditional | 05/03/2013SE |
Questions and answers
When was Artiglass NRFitTM Tip L.O.R. Glass Syringes cleared by the FDA?
Artiglass NRFitTM Tip L.O.R. Glass Syringes (K213800) received a 510(k) decision of Substantially Equivalent on May 19, 2022, 164 days after the submission was received.
What is the product code of K213800?
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.