PUR · Class II · 21 CFR 880.5860

FDA Product Code PUR: Vacuum Syringe

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.

Leading manufacturers include Inari Medical, Inc..

2
Total
2
Cleared
200d
Avg days
2017
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Vacuum Syringe Devices (Product Code PUR)

2 devices
1–2 of 2
Cleared Mar 26, 2024
Removal System Large Bore 60 cc Syringe
K233069
Inari Medical, Inc.
General Hospital · 182d

About Product Code PUR - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code PUR since 2017, with 2 receiving FDA clearance (average review time: 200 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

PUR devices are reviewed by the General Hospital panel. Browse all General Hospital devices →