Sterile Syringe with Fixed Safety Needle for Single Use
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212652 FDA 510(k)
- FDA Product Code
- MEG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A sterile syringe with a fixed safety needle for single use is a medical device designed for the aspiration and injection of fluids. It consists of a syringe barrel and a permanently attached needle equipped with a safety mechanism to reduce the risk of needlestick injuries after use.
This device is intended for manual, single-use only in medical settings. It is supplied sterile and must be disposed of after one use. The safety mechanism can be manually activated after needle withdrawal to cover the needle and minimize the risk of accidental needlesticks.
Frequently asked questions
What is the Sterile Syringe with Fixed Safety Needle for Single Use intended for?
This device is intended for the manual aspiration and injection of fluids in medical settings. It is designed for single use only and must be disposed of after one use to prevent cross-contamination and ensure patient safety.
How is the Sterile Syringe with Fixed Safety Needle supplied and is it sterile?
The device is supplied sterile and must remain in its sterile packaging until use. It is intended for single-use only and should be discarded after activation of the safety mechanism following needle withdrawal.
What safety feature does the fixed needle on this syringe include?
The syringe features a permanently attached needle with a safety mechanism that can be manually activated after needle withdrawal to cover the needle tip, thereby minimizing the risk of accidental needlestick injuries to healthcare workers.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Sterile Syringe with Fixed Safety Needle (7-DOSE SYRINGE) | Gemtier Medical, Sterile Syringe with Fixed Safety Needle for Single Use (K212652) — FDA ..., Safety Hypodermic Needle and Syringe | Gemtier Medical, Gemtier Medical (Shanghai) Inc Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212652 | Class II | Active |
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Manufacturer
- Manufacturer
- Gemtier Medical (Shanghai) Inc.
- FDA Applicant
- Gemtier Medical (Shanghai), Inc.
Sources (1)
- FDA 510(k) K212652 24 fields · synced Sep 21, 2026