PUR — Vacuum Syringe Class II

FDA Device Classification

Classification Details

Product Code
PUR
Device Class
Class II
Regulation Number
880.5860
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233069inari medicalRemoval System Large Bore 60 cc SyringeMarch 26, 2024
K163597merit medical systemsVacLok AT Vacuum SyringeJuly 27, 2017