K241385 is an FDA 510(k) clearance for the Omnifix Syringe NRFit. 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 B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on July 13, 2024, 59 days after receiving the submission on May 15, 2024.
This device falls under the General Hospital 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 | K241385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2024 |
| Decision Date | July 13, 2024 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| 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. |