FDA Product Code QEH: Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact
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.
Leading manufacturers include Artiglass Srl, B.Braun Medical, Inc. and Jiangsu Caina Medical Co.,Ltd.
5
Total
5
Cleared
204d
Avg days
2018
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact Devices (Product Code QEH)
5 devices
Cleared
Jul 13, 2024
Omnifix Syringe NRFit
B.Braun Medical, Inc.
General Hospital
59d
Cleared
May 19, 2022
Artiglass NRFitTM Tip L.O.R. Glass Syringes
Artiglass Srl
Anesthesiology
164d
Cleared
Dec 16, 2020
NRFit® Caps, Male and Female Neuraxial Tip Caps
International Medical Industries, Inc.
General Hospital
240d
Cleared
Sep 04, 2020
BD Syringe NRFit Lok and BD Syringe NRFit Slip
Becton, Dickinson and Company
General Hospital
354d
Cleared
Dec 14, 2018
NRFit Syringe
Jiangsu Caina Medical Co.,Ltd
General Hospital
204d
About Product Code QEH - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code QEH since 2018, with 5 receiving FDA clearance (average review time: 204 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.