Cleared Traditional

BD Syringe NRFit Lok and BD Syringe NRFit Slip

K192538 · Becton, Dickinson and Company · General Hospital

Sep 2020

Decision

354d

Days

Class 2

Risk

About This 510(k) Submission

K192538 is an FDA 510(k) clearance for the BD Syringe NRFit Lok and BD Syringe NRFit Slip, a Piston Syringe With Neuraxial Connector ? Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact (Class II — Special Controls, product code QEH), submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on September 4, 2020, 354 days after receiving the submission on September 16, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K192538 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2019
Decision Date	September 04, 2020
Days to Decision	354 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.