ConceptoMed AS received FDA 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the first size of the Luer-Jack® syringe.
“I am very pleased to receive FDA 510(k) market clearance for our first size of the Luer-Jack® Slip syringe. The FDA 510(k) market clearance represents another important milestone in our global company strategy and will open up potential of establishing a commercial presence of the Luer-Jack® in the world’s largest single US healthcare market”, said Christian Mide, M.D., CEO and founder of ConceptoMed.
About Luer-Jack®
Luer-Jack® is a user-friendly syringe, which will become an important contribution to procedure quality and aseptic procedures when handling medical connections – simply by its one-handed disconnection capability. Luer-Jack® is delivered in a simple to use and uniquely designed packaging – the Steri-Tilt™.
Health authorities and medical professionals now have the option of implementing a medical device with an integrated and user-friendly one-handed aseptic disconnection technique as part of the medical device itself.
A key element of a next-generation medical syringe could become the development away from using two hands during disconnections.
Luer-Jack® Slip syringes are already CE marked and sold by distributors in Europe.
For more information, please visit www.luerjack.com and/or contact:
| Christian Mide, CEO – christian.mide@conceptomed.com | +47 95 100 720 |
| Martinsen, Director QA & Reg. – marit.martinsen@conceptomed.com | +47 905 146 90 |
| Ann-Christine Jungmar, CCO – ann-christine.jungmar@conceptomed.com | +46 708 71 46 76 |
