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Greiner Vacuette Quickshield Complete

by Greiner Bio-One North America, Inc.

510(k) K072320

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Special NumberK072320 Date14 Sep 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1935-2012 FDA Class II initiated 2 Apr 2012

    : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable.

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  • Withdrawn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
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Vacutette Quickshield Complete is a Vacuum Blood Collection Set (per FDA nomenclature) designed for safe and secure blood collection. It combines a pre-threaded multiple-use drawing needle with a safety tube holder that includes a rotational shield to protect healthcare providers during and after venipuncture.

This device is supplied as a sterile, single-use unit in a blister pack and is intended for use in general hospital settings. The needle and holder assembly are engineered for compatibility with standard Vacutette blood collection tubes, ensuring proper sealing and sample integrity. The device carries FDA 510(k) clearance under K072320, classified under product code FMI, and is intended for reusable needle applications with single-use tube holders.

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