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510(k) K213800

Artiglass NRFitTM Tip L.O.R. Glass Syringes by Artiglass Srl — Product Code QEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2022
Date Received
December 6, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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.

Other clearances by Artiglass Srl

  • K122416 — ARTIGLASS L. O.R. GLASS SYRINGE (May 3, 2013)

Other clearances for product code QEH

  • K241385 — Omnifix Syringe NRFit (July 13, 2024)
  • K201031 — NRFit® Caps, Male and Female Neuraxial Tip Caps (December 16, 2020)
  • K192538 — BD Syringe NRFit Lok and BD Syringe NRFit Slip (September 4, 2020)
  • K181374 — NRFit Syringe (December 14, 2018)