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The Injector

by American Medical Innovations, Inc.

510(k) K862325

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 NumberK862325 Date27 Feb 1987ClearedStatusActive

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  • Withdrawn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
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

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

The device is an Introducer, Syringe Needle as defined in the openFDA device name field. It is a medical device classified under regulation number 880.6920 and assigned product code KZH.

It received FDA 510(k) clearance K862325 on February 27, 1987, as a substantially equivalent device under the traditional review pathway. The device is manufactured by American Medical Innovations, Inc. and is intended for use in a general hospital setting.

Questions

AI-generated answers, 1 Oct 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 INJECTOR used for?

    THE INJECTOR is an Introducer, Syringe Needle intended for use in a general hospital setting, as specified in its FDA 510(k) clearance and openFDA device name field.

  • How is THE INJECTOR supplied or configured for use?

    The device data does not specify supply configuration, sterility, single-use or reuse status, sizes, models, or storage requirements; these details are not included in the provided information.

  • What regulatory pathway was used for THE INJECTOR's clearance?

    THE INJECTOR received FDA 510(k) clearance K862325 on February 27, 1987, through the traditional review pathway as a substantially equivalent device.