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 Merit Medical Systems, Inc. and 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
Cleared
Mar 26, 2024
Removal System Large Bore 60 cc Syringe
Inari Medical, Inc.
General Hospital
182d
Cleared
Jul 27, 2017
VacLok AT Vacuum Syringe
Merit Medical Systems, Inc.
General Hospital
218d
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.