NeedleVISE Large-Bore Sharps Securing Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K043249 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 NeedleVISE Large-Bore Sharps Securing Device is a sharps securing device designed to safely contain and immobilize contaminated needles, reducing the risk of accidental needle sticks. It is classified as a large-bore sharps securing device, capable of securing needles ranging from 8 gauge to 27 gauge, ensuring securement of both large and small-bore needles in clinical settings.
This device is intended for single-use in clinical environments, such as hospitals and medical facilities, to prevent tray penetration and improve safety during sharps handling. Supplied sterile, it requires no special storage conditions beyond standard medical device protocols. Authorized under FDA 510(k) clearance (K043249), it adheres to regulatory standards for sharps management in healthcare settings.
Frequently asked questions
What needle sizes can the NeedleVISE Large-Bore Sharps Securing Device secure, and why is this range important in clinical settings?
The NeedleVISE Large-Bore Sharps Securing Device is designed to securely immobilize needles ranging from 8 gauge to 27 gauge, covering both large-bore (e.g., IV catheters, surgical needles) and smaller-bore (e.g., insulin syringes, diagnostic needles) applications. This broad range is critical in clinical settings like hospitals, where a single device must handle diverse sharps—from high-flow IV needles to fine procedural needles—while preventing accidental sticks and tray penetration during disposal.
Is this device meant for reuse, or is it intended for single-use only? How does that affect its safety and handling?
The NeedleVISE Large-Bore Sharps Securing Device is intended for single-use only, as explicitly stated in its design. This ensures maximum safety by eliminating the risk of cross-contamination or device failure from repeated use. Single-use also simplifies handling protocols—clinicians can discard it immediately after securing a contaminated needle, reducing exposure risks and adhering to sharps injury prevention best practices.
How should I store this device before use, and are there any special conditions I need to follow?
The device is supplied sterile, but no special storage conditions are required beyond standard medical device protocols. It can be stored in its original packaging under typical clinical conditions (e.g., room temperature, protected from direct sunlight) until ready for use. This makes it convenient for hospitals and facilities where space and logistical constraints are common, as it doesn’t demand refrigeration or humidity-controlled environments.
What makes this device different from other sharps containers or securing devices, particularly in how it prevents accidental needle sticks?
Unlike traditional sharps containers—which primarily rely on rigid walls to contain needles—the NeedleVISE is a sharps securing device that physically immobilizes the needle in place before disposal. This design prevents tray penetration (where needles could pierce through disposal trays) and reduces the risk of accidental sticks during handling. Its mechanical securing mechanism is particularly useful in fast-paced clinical environments where quick, safe disposal is essential.
How do I know this device meets regulatory standards for sharps management, and what does its FDA clearance (K043249) mean for my facility?
The device holds FDA 510(k) clearance (K043249), which means it has been reviewed and deemed substantially equivalent to a legally marketed predicate device under the Traditional 510(k) review pathway. This clearance confirms it meets U.S. regulatory standards for sharps management, including safety and performance requirements. For your facility, this indicates compliance with FDA guidelines for sharps injury prevention, though you should always verify local protocols align with your institution’s policies.
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: ATRION MEDICAL NEEDLEVISE MANUAL Pdf Download | ManualsLib, Needlevise Sharps Securement | Nordson MEDICAL, PDF NeedleVISE® - Atrion Medical, Atrion Needlevise Large-bore Sharps Securing Device
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043249 | Class II | Active |
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Manufacturer
- Manufacturer
- Atrion Medical Products, Inc.
Sources (1)
- FDA 510(k) K043249 24 fields · synced Oct 6, 2026