Disposabel Syringe with permanently attached needle, Safety Syringe with perman…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220204 FDA 510(k)
- FDA Product Code
- FMF 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)
The Disposable Syringe with Permanently Attached Needle is a medical device designed for single-use administration of medications or fluids. It features a permanently attached needle to ensure safety and prevent reuse.
This syringe is supplied as a sterile, single-use device and is not intended for reuse. It is available in various sizes and is authorized under FDA 510K, MDD, and MDR regulatory frameworks.
Frequently asked questions
What is the purpose of the Disposable Syringe with permanently attached needle?
This syringe is designed for single-use administration of medications or fluids, featuring a permanently attached needle to ensure safety and prevent reuse.
Is the syringe sterile and can it be reused?
The syringe is supplied as a sterile, single-use device and is not intended for reuse to maintain safety and prevent cross-contamination.
What sizes are available for this syringe?
The syringe is available in various sizes, though specific measurements are not provided in the device data.
What regulatory authorizations does this syringe have?
The syringe is authorized under FDA 510K, MDD, and MDR regulatory frameworks, indicating it meets specific safety and performance requirements.
How is the syringe supplied and stored?
The syringe is supplied as a sterile, single-use device, though specific storage conditions are not detailed in the provided information.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220204 | Class II | Active |
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Manufacturer
- Manufacturer
- Anhui Tiankang Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K220204 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026