DeviceClearance

Product code PQX— General Hospital

Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

Classification name
Epinephrine Syringe
Device class
Class 2
Regulation
21 CFR 880.5860
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

FDA classification definition

“Intended for intramuscular or subcutaneous injection of epinephrine.”

— U.S. Food and Drug Administration, device classification record for product code PQX under 21 CFR 880.5860, via openFDA

Market context for product code PQX

FDA has cleared 2 devices under product code PQX between 2017 and 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PQX

Recent clearances under product code PQX

Data sourced from openFDA. This site is unofficial and independent of the FDA.