510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PURClass II

Vacuum Syringe

21 CFR 880.5860 / General Hospital
FDA source (opens on fda.gov)

PUR is the FDA product code for Vacuum Syringe, a class II device type, regulated under 21 CFR 880.5860. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PUR
Device name
Vacuum Syringe
FDA 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.
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PUR

By decision year
2 clearances under product code PUR with a decision year between 2017 and 2024, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PUR by decision year
YearClearances
20171
20241

Applicants with the most clearances

Product code PUR
Applicants holding the most 510(k) clearances under product code PUR
ApplicantClearances
Inari Medical, Inc.1
Merit Medical Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code