Cleared Traditional

NRFit? Caps, Male and Female Neuraxial Tip Caps

K201031 · International Medical Industries, Inc. · General Hospital
Dec 2020
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K201031 is an FDA 510(k) clearance for the NRFit? Caps, Male and Female Neuraxial Tip Caps, a Piston Syringe With Neuraxial Connector ? Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact (Class II — Special Controls, product code QEH), submitted by International Medical Industries, Inc. (Pompano Beach, US). The FDA issued a Cleared decision on December 16, 2020, 240 days after receiving the submission on April 20, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K201031 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2020
Decision Date December 16, 2020
Days to Decision 240 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.