Verisafe Safety Sterile Needles (SSN)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K254273 FDA 510(k)
- FDA Product Code
- FMI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Verisafe Safety Sterile Needles (SSN) are classified as sterile needles for single-use injection and withdrawal (FDA Product Code: FMI). These devices incorporate a safety mechanism designed to immediately cover the needle upon use, reducing the risk of accidental needle-stick injuries during medical procedures. They are intended for general-purpose fluid administration and aspiration in clinical settings, adhering to sterile barrier requirements for patient safety.
Supplied sterile and intended for single-use, these needles are regulated under FDA 510(k) clearance (K254273) and EU MDR compliance. The safety shield activates post-procedure to encapsulate the needle, ensuring compliance with infection control protocols. No reusable or MRI-compatible variants are specified; storage must adhere to sterile packaging integrity until first use. Authorisations include FDA clearance and MDR conformity, with no additional regulatory claims stated.
Frequently asked questions
Are these needles designed for reuse in any capacity, or are they strictly for single-use only?
The Verisafe Safety Sterile Needles (SSN) are explicitly intended for single-use only, as stated in the device description. The safety mechanism and sterile packaging are engineered to ensure patient and clinician safety during a single procedure, with no indication or approval for reuse. Discarding after use aligns with infection control protocols and regulatory compliance.
What clinical procedures are these needles typically used for, and how does the safety feature work?
These needles are designed for general-purpose fluid administration and aspiration in clinical settings, such as injections, withdrawals, or IV line access. The safety feature activates immediately after use, covering the needle tip to prevent accidental needle-stick injuries—a critical safety enhancement for procedures like injections or blood draws.
How should I store these needles before first use, and what should I check for?
Storage must maintain the sterile packaging integrity until first use. Verify the seal is intact and the packaging is unopened to ensure sterility. Avoid exposure to moisture, extreme temperatures, or contamination, as these could compromise the sterile barrier and regulatory compliance.
Are there different sizes or models available, and if so, how do I identify them?
The specifications provided do not detail specific sizes or models beyond the general classification as sterile needles for single-use injection and withdrawal. For exact gauge or length options, refer to the manufacturer’s product catalog or technical documentation, as these details are not included in the regulatory data.
What regulatory pathways have these needles undergone, and how does that affect their use?
The Verisafe SSN has undergone FDA 510(k) clearance (K254273) and EU MDR compliance, confirming they meet U.S. and European safety standards for sterile, single-use needles. This ensures adherence to infection control protocols and regulatory requirements for clinical use in those markets, though no additional indications or claims are implied beyond their stated purpose.
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: Verisafe Safety Sterile Needles (SSN) (K254273) — FDA 510(k ..., K254273 FDA 510(k) - Verisafe Safety Sterile Needles (SSN), Promisemed, Verisafe Safety sterile needles (K222271) — FDA 510 (k) | Innolitics
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 | K254273 | Class II | Active |
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Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
Sources (2)
- FDA 510(k) K254273 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026