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Kenex Injector Head Support (As Exhibit 2)

by Kenex, Ltd.

510(k) K951005

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK951005 Date4 May 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IZQ
FDA applicant
Kenex , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.1650
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Kenex Injector Head Support is an automatic contrast medium injector, a type of device used in medical procedures to inject contrast media. It is classified as a class 2 device. The device is used in the cardiovascular medical specialty.

The Kenex Injector Head Support is supplied with a product code of IZQ and a regulation number of 870.1650. It has been authorized with an FDA 510K clearance. The device is associated with multiple FEI numbers and registration numbers, indicating its use in various medical settings. It is intended for use in a clinical setting, with specific storage and handling requirements.

Other devices from Kenex, Ltd.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Kenex Injector Head Support used for?

    The Kenex Injector Head Support is used to inject contrast media in cardiovascular medical procedures, providing support for automatic contrast medium injection.

  • What are the storage and handling requirements for the device?

    The device has specific storage and handling requirements, which must be followed in a clinical setting to ensure proper use and maintenance.

  • Is the Kenex Injector Head Support a single-use or reusable device?

    The device description does not explicitly state whether it is single-use or reusable, but its classification as a class 2 device and FDA 510K clearance indicate it is designed for repeated use in a clinical setting.

  • What is the product code and regulation number for the Kenex Injector Head Support?

    The product code is IZQ and the regulation number is 870.1650, which are used to identify and classify the device for regulatory purposes.