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

Epinephrine Syringe

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

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

Classification record

Product code
PQX
Device name
Epinephrine Syringe
FDA definition
Intended for intramuscular or subcutaneous injection of epinephrine.
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 PQX

By decision year
2 clearances under product code PQX with a decision year between 2017 and 2018, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PQX by decision year
YearClearances
20171
20181

Applicants with the most clearances

Product code PQX
Applicants holding the most 510(k) clearances under product code PQX
ApplicantClearances
Certa Dose2

Companies listing this code with FDA

Companies whose registered establishments list this code