PUR

Vacuum Syringe

Product code
PUR
Device name
Vacuum Syringe
Device class
Class 2
21 CFR
21 CFR 880.5860
Medical specialty
General Hospital
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-03-26.

NumberDecision dateApplicantDevice nameSummary
K2330692024-03-26Inari Medical, Inc.Removal System Large Bore 60 cc SyringePDF

1 summaries are archived here for direct download.

Official FDA classification page: PUR
Classification and pathway per current FDA publications. Data from openFDA (CC0).