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 and B.Braun Medical, Inc..
FDA 510(k) Cleared Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact Devices (Product Code QEH)
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 increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QEH have taken an average of 59 days to reach a decision - down from 241 days historically, suggesting improved FDA processing for this classification.
QEH devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →