K213800 is an FDA 510(k) clearance for the Artiglass NRFitTM Tip L.O.R. Glass Syringes. This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.5860. 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..
| 510(k) Number | K213800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |