Epinephrine Syringe
The Epinephrine Syringe is a medical device intended for intramuscular or subcutaneous injection of epinephrine, a critical medication used in emergency treatment of severe allergic reactions (anaphylaxis) and other acute conditions. It is classified as FDA Class 2 under 21 CFR 880.5860 in the General Hospital specialty, requiring 510(k) premarket notification. Product code PQX; not an implant and not life-sustaining.
Research product code PQX in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PQX
- Device Class
- FDA class 2
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
Intended for intramuscular or subcutaneous injection of epinephrine.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.