Cleared Traditional

Removal System Large Bore 60 cc Syringe

K233069 · Inari Medical, Inc. · General Hospital
Mar 2024
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K233069 is an FDA 510(k) clearance for the Removal System Large Bore 60 cc Syringe, a Vacuum Syringe (Class II — Special Controls, product code PUR), submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on March 26, 2024, 182 days after receiving the submission on September 26, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K233069 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2023
Decision Date March 26, 2024
Days to Decision 182 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code PUR — Vacuum Syringe
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860
Definition The Vacuum Syringe Is Intended To Be Used As A General Purpose Syringe For Injection And Withdrawal Of Fluids And Can Be Locked In Place To Create A Vacuum For Removal Of Fluid And/or Tissue From The Body In The Form Of Thrombus, Abscess Fluid, And Infected Fluid.