EZ-JECT Introducer Syringe Needle
510(k) K051667
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051667 | Date27 Sep 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Ez-Ject
- 510(k) Number
- FDA Product Code
- KZH
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6920
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The EZ-JECT Introducer Syringe Needle is a medical device classified as an introducer and syringe needle, designed for facilitating the insertion of fluids or instruments into the body. It is intended to provide a smooth and controlled pathway for intravenous access, reducing patient discomfort during procedures.
This device is supplied as a single-use, non-sterile product (unless sterilized by the user) and is regulated under 21 CFR 880.6920. It is cleared for use in general hospital settings and falls under FDA Class II regulatory classification (product code KZH). The device requires proper handling and storage to maintain its integrity before use.
Questions
AI-generated answers, 1 Oct 2026
What is the EZ-JECT Introducer Syringe Needle designed for?
The EZ-JECT Introducer Syringe Needle is specifically designed to facilitate the insertion of fluids or medical instruments into the body, particularly for intravenous access. Its purpose is to create a smooth and controlled pathway, minimizing patient discomfort during procedures like catheter insertion or blood draws. The device’s design ensures ease of use in clinical settings where precise and gentle insertion is critical.
Is the EZ-JECT Introducer Syringe Needle sterile when supplied?
No, the EZ-JECT Introducer Syringe Needle is supplied as a non-sterile product. Users are responsible for sterilizing the device before use to ensure safety and compliance with medical standards. This is a standard practice for single-use devices that require terminal sterilization prior to clinical application.
How is the EZ-JECT Introducer Syringe Needle regulated and where is it cleared for use?
The EZ-JECT Introducer Syringe Needle is regulated under 21 CFR 880.6920 and falls under FDA Class II classification with the product code KZH. It is cleared for use in general hospital settings and was granted 510(k) clearance through the traditional review process by the FDA’s General Hospital (HO) Advisory Committee. This clearance confirms its compliance for standard medical procedures requiring introducer syringe needles.
What sizes or models of the EZ-JECT Introducer Syringe Needle are available?
The EZ-JECT Introducer Syringe Needle is available in multiple gauge sizes, as indicated by the FEI numbers listed in the regulatory records (e.g., 3002806521, 3013188547, etc.). These variations allow clinicians to select the appropriate gauge for different patient needs, such as pediatric or adult intravenous access. The exact specifications, including needle length and gauge, should be referenced in the product documentation provided by Indolor, Ltd.
How should the EZ-JECT Introducer Syringe Needle be stored to maintain its integrity?
The EZ-JECT Introducer Syringe Needle must be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. Since it is a single-use device, it should remain in its original packaging until ready for terminal sterilization. Proper storage ensures the device remains free from damage or degradation, preserving its functionality for safe clinical use.