Whisperject Autoinjector

FDA 510(k) K141384 · Scandinavian Health Limited

Substantially Equivalent

510(k) numberK141384

Submission

Device name
Whisperject Autoinjector
Applicant
Scandinavian Health Limited
Deerfield Beach, FL, US
Received
May 27, 2014
Decision date
September 12, 2014
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
KZH – Introducer, Syringe Needle
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6920
Specialty
General Hospital

Other 510(k)s with product code KZH

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K243232GripMateKZH · Traditional Synthon Hispania S.L.12/02/2024SE
K213429AccuSert Needle InserterKZH · Traditional Emed Technologies Corporation10/20/2022SE
K163400Orbit InserterKZH · Traditional Ypsomed AG07/26/2017SE
K160860MiniMed Quick-serterKZH · Traditional Medtronic Minimed09/22/2016SE
K124026Lobster Auto-InjectorKZH · Traditional Scandinavian Health Limited09/13/2013SE
K122837Autoject 2 for Glassy SyringeKZH · Special Owen Mumford, Ltd.10/15/2012SE
K111467Flexi-Q DV and DVR Auto-InjectorsKZH · Traditional Elcam Medical Acal02/09/2012SE
K082587Auto-Safety INJECTOR-2 (ASI-2)KZH · Traditional Medical House Products Limited10/02/2008SE
K073476Compact Auto-Safety Injector (Casi)KZH · Traditional Medical House (Asi) Limited03/07/2008SE
K062339Dermotherap GunKZH · Traditional Dermoequipos S.R.L.02/05/2007SE

More from Dermoequipos S.R.L.

510(k)DeviceDecision
K124026Lobster Auto-InjectorKZH · Traditional 09/13/2013SE
K120191Push-On Needle 30GX8MMFMI · Traditional 05/23/2012SE
K954729Pen-Inject 2.25KZH · Traditional 01/29/1996SE

Questions and answers

When was Whisperject Autoinjector cleared by the FDA?

Whisperject Autoinjector (K141384) received a 510(k) decision of Substantially Equivalent on September 12, 2014, 108 days after the submission was received.

What is the product code of K141384?

The FDA product code is KZH – Introducer, Syringe Needle, a Class II (moderate risk) device regulated under 21 CFR 880.6920.