Sterile Hypodermic Safety Syringes for Single Use
by Jiangxi Hongda Medical Equipment Group Ltd.
510(k) K163162
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163162 | Date20 Mar 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MEG
- FDA applicant
- Jiangxi Hongda Medical Equipment Group , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
Sterile Hypodermic Safety Syringes for Single Use are Class II medical devices designed for the safe administration or withdrawal of fluids in clinical settings. These syringes incorporate an antistick safety feature to mitigate the risk of needle-stick injuries, ensuring enhanced protection for healthcare professionals.
Intended for single-use in general hospital environments, these syringes are supplied in sterile packaging to prevent contamination. They are not reusable and must be discarded after use. The device holds FDA 510(k) clearance under regulation 880.5860, with multiple registration numbers for compliance. No MRI compatibility information is provided, and specific sizes are not detailed in the data.
From the manufacturer
Jiangxi Hongda Medical Equipment Group Ltd. It is an enterprise recognized by the State Food and Drug Administration as a single-use sterile medical device series product registration certificate Company Profile Jiangxi Hongda Group was established in 1995. It is a large-scale enterprise specializing in the production of disposable sterile medical device products.
Other devices from Jiangxi Hongda Medical Equipment Group Ltd.
See all devices from Jiangxi Hongda Medical Equipment Group Ltd. →
Questions
AI-generated answers, 20 Sep 2026
Are these syringes designed for reuse in clinical settings, or are they meant to be used only once?
These syringes are explicitly designed for single-use only in general hospital environments. The manufacturer emphasizes they must be discarded after use to prevent contamination and ensure patient safety.
What safety feature distinguishes these syringes from standard hypodermic syringes?
These syringes include an antistick safety feature, which helps reduce the risk of needle-stick injuries—a common hazard for healthcare professionals during fluid administration or withdrawal.
How should these syringes be stored to maintain their sterility before use?
The syringes are supplied in sterile packaging, which must remain intact until use. Proper storage in a clean, dry environment away from direct sunlight or extreme temperatures is implied to preserve sterility, though specific storage conditions aren’t detailed.
What regulatory pathway was followed for FDA clearance of these syringes?
The syringes received FDA 510(k) clearance under regulation 880.5860, classified as a Class II device with a Traditional 510(k) pathway. The submission was reviewed by the Hospital/Orthopedic (HO) Advisory Committee and deemed Substantially Equivalent (SESE) to a predicate device.