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QEHClass II

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

21 CFR 880.5860 / General Hospital

QEH is the FDA product code for Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact, a class II device type, regulated under 21 CFR 880.5860. FDA's definition for this code reads: "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...". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QEH
Device name
Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
FDA 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.
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code QEH

By decision year
5 clearances under product code QEH with a decision year between 2018 and 2024, 2020 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QEH by decision year
YearClearances
20181
20202
20221
20241

Applicants with the most clearances

Product code QEH
Applicants holding the most 510(k) clearances under product code QEH
ApplicantClearances
Artiglass SRL1
B.Braun Medical, Inc.1
Becton Dickinson & Co1
Intl. Medical Industries1
Jiangsu Caina Medical Co., Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code