Sterile Hypodermic Syringes for Single Use
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213811 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)
This device is a sterile hypodermic syringe designed for single-use administration of medications, fluids, or vaccines. Classified under the nomenclature for injection devices, it is intended for subcutaneous, intramuscular, or intravenous use in clinical settings, ensuring precise dosing and minimal patient discomfort.
Supplied sterile and packaged individually, these syringes are intended for use in general hospital environments. They are non-reusable, require no special storage conditions beyond protection from contamination, and comply with FDA 510(k) clearance (K213811) and EU MDR authorisations. Sizes and configurations are specified in the product documentation, adhering to regulatory standards for sterile medical devices.
Frequently asked questions
Are these syringes reusable, or are they meant for single-use only?
These syringes are explicitly designed for single-use only. The manufacturer and regulatory documentation emphasize their non-reusable nature to ensure patient safety and sterility, preventing contamination or cross-infection risks associated with reuse.
What types of medical procedures or injections can these syringes be used for?
The syringes are intended for subcutaneous, intramuscular, or intravenous administration of medications, fluids, or vaccines in clinical settings. Their design ensures precise dosing and minimizes patient discomfort, making them suitable for general hospital use.
How should these syringes be stored before use?
No special storage conditions are required beyond protection from contamination. Since they are sterile and packaged individually, they should remain in their original packaging until ready for use to maintain sterility and integrity.
What regulatory approvals do these syringes have, and how does that affect their use?
These syringes hold FDA 510(k) clearance (K213811) and comply with EU MDR authorizations, confirming they meet U.S. and European regulatory standards for sterile injection devices. This ensures they can be legally marketed and used in both regions under the specified indications.
Are the syringe sizes and configurations standardized, or do they vary?
The syringes come in various sizes and configurations, as detailed in the manufacturer’s product documentation. These adhere to regulatory standards for sterile medical devices, ensuring compatibility with common clinical practices and precise dosing requirements.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K213811 | Class II | Active |
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Manufacturer
- Manufacturer
- Berpu Medical Technology Co., Ltd
- FDA Applicant
- Berpu Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K213811 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026