Cleared Traditional

Omnifix Syringe NRFit

K241385 · B.Braun Medical, Inc. · General Hospital
Jul 2024
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K241385 is an FDA 510(k) clearance for the Omnifix Syringe NRFit, 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 review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K241385 FDA.gov
FDA Decision Cleared 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

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.