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Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Preattached Needle

by Medimop Medical Projects, Ltd.

510(k) K963583

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 NumberK963583 Date7 Oct 1996ClearedStatusActive

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  • Withdrawn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
LHI
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Mixject Dispensing Pin is an intravenous fluid transfer set designed to facilitate the movement of fluids between containers. It features a detachable vial holder and is available in a configuration that includes a preattached needle to assist in the transfer process.

This device is supplied as a medical accessory and has received FDA 510(k) clearance under K963583. It is classified under product code LHI and is intended for use in general hospital settings.

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Questions

AI-generated answers, 27 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 primary function of the Mixject Dispensing Pin?

    The Mixject Dispensing Pin is an intravenous fluid transfer set specifically designed to facilitate the movement of fluids between different containers within a clinical environment.

  • What configurations are available for this device?

    The device is available with a detachable vial holder, and it can also be supplied in a configuration that includes a preattached needle to assist in the fluid transfer process.

  • In what environment is this device intended to be used?

    The Mixject Dispensing Pin is intended for use in general hospital settings, where it serves as a medical accessory for fluid management tasks.

  • What is the regulatory status of the Mixject Dispensing Pin?

    This device has received FDA 510(k) clearance under K963583 and is classified under product code LHI, confirming its status as a cleared medical accessory.