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AccuSert Needle Inserter

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K213429

by EMED Technologies Corporation

Identifiers

510(k) Number
K213429 FDA 510(k)
FDA Product Code
KZH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6920 FDA 510(k)
Regulation Number
880.6920 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The AccuSert Needle Inserter is a Syringe Needle Introducer, designed to facilitate precise and controlled insertion of needles into subcutaneous tissue. It is classified as a Class II medical device and supports various syringe needle sizes for infusion or drug delivery applications in general hospital settings.

This device is intended for single-use and is supplied sterile, ensuring safe and hygienic use in clinical environments. It is compatible with multiple needle sizes and is regulated under FDA 510(k) clearance and MDR compliance. Storage and handling follow standard sterile medical device protocols to maintain integrity and functionality.

Frequently asked questions

What types of syringe needles is the AccuSert Needle Inserter compatible with, and how does this affect its use in clinical settings?

The AccuSert Needle Inserter is designed to work with a wide range of syringe needle sizes, as indicated by the extensive list of compatible needle types referenced in its regulatory data (e.g., FEI numbers and registration numbers). This versatility makes it suitable for various infusion or drug delivery applications in general hospital settings, ensuring flexibility for clinicians when selecting the appropriate needle gauge for their patients. The device’s compatibility with multiple needle sizes helps streamline workflows and reduces the need for additional accessories.

Is the AccuSert Needle Inserter intended for reuse, or is it meant to be used only once? How should it be handled to maintain safety?

The AccuSert Needle Inserter is explicitly designed for single-use only, as stated in its description. This ensures patient safety and hygiene in clinical environments. To maintain sterility and functionality, it should be stored and handled according to standard sterile medical device protocols—typically in a sealed, sterile packaging until use, and then disposed of immediately after a single application to prevent contamination or cross-infection.

How is the AccuSert Needle Inserter regulated, and what does this mean for healthcare providers using it?

The AccuSert Needle Inserter is regulated under FDA 510(k) clearance and MDR compliance, confirming it meets stringent safety and performance standards for Class II medical devices. For healthcare providers, this means the device has undergone rigorous evaluation to ensure its effectiveness and safety for precise needle insertion in subcutaneous tissue. The regulatory route also implies that it adheres to manufacturing and quality control practices required for medical devices in general hospital settings, giving providers confidence in its reliability.

What storage conditions should be followed for the AccuSert Needle Inserter to ensure it remains functional and sterile?

Since the AccuSert Needle Inserter is supplied sterile, it must be stored in accordance with standard sterile medical device protocols to preserve its integrity. This typically includes keeping it in its original, unopened packaging in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. The packaging should remain intact until immediate use to prevent contamination, and any expired or compromised units should be discarded promptly.

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

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
EMED Technologies Corporation

Sources (2)

  • FDA 510(k) K213429 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026