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Terumo Europe N.V. Announces FDA 510k Clearance of a Hypodermic Needle with Integrated Passive Sharps Protection

01/07/2011 - Leuven, Belgium

Terumo Europe N.V. is pleased to announce that it has now received FDA 510k clearance from the US Food and Drug Administration for its K-Pack Surshield™ after obtaining CE marking in February this year.

​This means that the 25G needle will now be available to US customers as well. Recently Terumo also applied for FDA 510k clearance for the 27G needle, for which the CE marking procedure is already in process.

These two new sizes offer the pharmaceutical industry additional options for intramuscular and subcutaneous applications with integrated sharps injury protection features. Moreover, it provides the user with Terumo’s well renowned high quality needle for minimal patient trauma.

Dedicated to the pharmaceutical industry, K-Pack Surshield™ is an innovative hypodermic needle with an integrated passive sharps protection feature for use with (pre)-filled syringes.

The device geometry is designed to allow for automated manipulations during packaging processes, which makes it ideal for bundling and inclusion into the secondary packaging of parenteral medication. K-Pack Surshield™ is individually packed in a rigid packaging with a tamper-evident and colour-coded label.

About Terumo

Terumo is a global medical technology company dedicated to the development, manufacturing and marketing of quality medical products and services used in a wide range of therapeutic applications.

For more information on Terumo’s Global Pharmaceutical Solutions, please visit http://www.terumo-europe.com/pharmaceutical/ or contact gps.info@terumo-europe.com.

Contact: William Dierick
Business Development Manager GPS
Terumo Europe N.V.
Tel: +32 1638 1450, Email: william.dierick@terumo-europe.com