Pharma-Plast Syringe With Needle
by Zimmar Consulting, Ltd. 510(k)
Active
510(k) K843472
Overview
The Pharma-Plast Syringe With Needle is a disposable, single-use medical device classified under the FDA product code FMF. It is designed for the administration of liquids, such as medications or vaccines, into the human body through injection. Constructed with a plastic barrel and attached needle, it ensures precise dosing and safe delivery of substances.
This device is intended for use in general hospital settings and has undergone FDA review under a 510(k) clearance process, designated as K843472. Supplied sterile and intended for one-time use, it requires no special storage conditions beyond standard medical inventory practices. The clearance was granted in 1984 under the Traditional 510(k) pathway, with the device deemed substantially equivalent to the predicate.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843472 | Date31 Oct 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FMF
- FDA applicant
- Zimmar Consulting , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Zimmar Consulting, Ltd.
Questions
What is the Pharma-Plast Syringe With Needle used for?
This device is designed for the administration of liquids such as medications or vaccines into the human body through injection. Its plastic barrel and attached needle ensure accurate dosing and safe delivery, making it suitable for general hospital use.
Is the Pharma-Plast Syringe With Needle sterile and single-use?
Yes, the Pharma-Plast Syringe With Needle is supplied sterile and intended for one-time use only. This design minimizes contamination risk and ensures patient safety during administration.
What storage conditions are required for this syringe?
No special storage conditions are required beyond standard medical inventory practices. Since it is single-use and sterile, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures.
What regulatory clearance does this syringe have?
The Pharma-Plast Syringe With Needle received FDA clearance under the 510(k) pathway, specifically clearance number K843472, in 1984. It was deemed substantially equivalent to a predicate device under the Traditional 510(k) review process.
Are there different sizes or models available for this syringe?
The provided specifications do not detail specific sizes or models beyond its classification as a disposable syringe with needle under product code FMF. For exact volume options, refer to the manufacturer’s catalog or technical documentation.