Cleared Special

Artiglass NRFitTM Tip L.O.R. Glass Syringes

K213800 · Artiglass Srl · Anesthesiology
May 2022
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K213800 is an FDA 510(k) clearance for the Artiglass NRFitTM Tip L.O.R. Glass Syringes, a Piston Syringe With Neuraxial Connector ? Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact (Class II — Special Controls, product code QEH), submitted by Artiglass Srl (Due Carrare, IT). The FDA issued a Cleared decision on May 19, 2022, 164 days after receiving the submission on December 6, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K213800 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2021
Decision Date May 19, 2022
Days to Decision 164 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code QEH — Piston Syringe With Neuraxial Connector ? Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860
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.