Cleared Traditional

NRFit Syringe

K181374 · Jiangsu Caina Medical Co.,Ltd · General Hospital
Dec 2018
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K181374 is an FDA 510(k) clearance for the NRFit Syringe, a Piston Syringe With Neuraxial Connector ? Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact (Class II — Special Controls, product code QEH), submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on December 14, 2018, 204 days after receiving the submission on May 24, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K181374 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2018
Decision Date December 14, 2018
Days to Decision 204 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.