510(k) K181374
K181374 is an FDA 510(k) premarket notification submitted by Jiangsu Caina Medical Co.,Ltd for the device "NRFit Syringe". The FDA issued a decision of Substantially Equivalent on December 14, 2018. The device falls under product code QEH (Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact), a Class II device regulated under 21 CFR 880.5860. Jiangsu Caina Medical Co.,Ltd has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2018
- Date Received
- May 24, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
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.