DeviceClearance

Product code QEH— General Hospital

Artiglass NRFitTM Tip L.O.R. Glass Syringes

Classification name
Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
Device class
Class 2
Regulation
21 CFR 880.5860
Advisory panel
General Hospital
Total cleared
5
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QEH under 21 CFR 880.5860, via openFDA

Market context for product code QEH

FDA has cleared 5 devices under product code QEH between 2018 and 2024, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QEH

Recent clearances under product code QEH

Data sourced from openFDA. This site is unofficial and independent of the FDA.