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Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact

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

Authoritative
FDA Device Classification database
Machine
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