Pharmajet 0.1 ML Intradermal Needle-Free Injection System

FDA 510(k) K110456 · Pharmajet, Inc.

Substantially Equivalent

510(k) numberK110456

Submission

Device name
Pharmajet 0.1 ML Intradermal Needle-Free Injection System
Applicant
Pharmajet, Inc.
Golden, CO, US
Received
February 16, 2011
Decision date
March 2, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
KZE – Injector, Fluid, Non-Electrically Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5430
Specialty
General Hospital

Other 510(k)s with product code KZE

510(k)DeviceApplicantDecision
K121270Bioject Needle-Free Injection Management SystemKZE · Traditional Bioject Medical Technologies, Inc.07/19/2012SE
K111517Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector…KZE · Special Pharmajet, Inc.07/27/2011SE
K090959Lectrajet Needle-Free Injection System, Model: M3 RaKZE · Traditional D'Antonio Consultants International, Inc. (Dci)12/24/2009SE
K090003ZetajetKZE · Abbreviated Bioject, Inc.04/02/2009SE
K081532Pharmajet Needle-Free Injection SystemKZE · Traditional Pharmajet, Inc.02/26/2009SE
K082138Airgent, Model AG7000010KZE · Traditional Perfaction, Inc.01/23/2009SE
K060819Cool.Click 2KZE · Traditional Medical House Products Limited06/16/2006SE
K051985Biovalve Mini-Ject Needlefree InjectorKZE · Special Biovalve Technologies, Inc.08/17/2005SE
K050734Cool.ClickKZE · Traditional Bioject, Inc.06/03/2005SE
K041239Genesis Medical Technologies, Inc. Pharmajet Needle-Free Injector, Model M2000KZE · Traditional Genesis Medical Technology, Inc.11/08/2004SE

More from Genesis Medical Technology, Inc.

510(k)DeviceDecision
K111517Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector…KZE · Special 07/27/2011SE
K081532Pharmajet Needle-Free Injection SystemKZE · Traditional 02/26/2009SE

Questions and answers

When was Pharmajet 0.1 ML Intradermal Needle-Free Injection System cleared by the FDA?

Pharmajet 0.1 ML Intradermal Needle-Free Injection System (K110456) received a 510(k) decision of Substantially Equivalent on March 2, 2011, 14 days after the submission was received.

What is the product code of K110456?

The FDA product code is KZE – Injector, Fluid, Non-Electrically Powered, a Class II (moderate risk) device regulated under 21 CFR 880.5430.