# Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
> **Product code: QEH** · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5860
## Classification
- **FDA Product Code:** QEH
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 880.5860
- **Review panel:** HO
- **Medical specialty:** General Hospital
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 5
- **Registered establishments:** 15
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QEH)
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