Kossel Medtech’s self developed Giranel® Guiding Sheath Set has successfully obtained US FDA 510(k) market clearance following regulatory review. This marks the third major market regulatory approval for the product, complementing its existing NMPA certification and EU CE-MDR certification.
Giranel® Guiding Sheath Set features a dual stiffness shaft construction with a soft distal tip. Equipped with hydrophilic coating, inner lumen PTFE coating and stainless steel spring coil reinforcement, the product balances kink resistance and pushability performance while minimizing vascular injury. Its proximal passive hemostasis valve integrated with a three-way stopcock enables reliable hemostasis and intraoperative fluid infusion, delivering a solution for vascular access establishment to reach distal lesions.
Kossel keeps expanding its product portfolio. Previously, Falexpand® Peripheral HP PTA Balloon Dilatation Catheter, Falspeed® PTA Balloon Dilatation Catheter, Sabelly® NC PTA Balloon Dilatation Catheter, and Selebrek® Coronary Scoring Balloon Dilatation Catheter have obtained US FDA clearances, covering both peripheral and coronary product lines. The recent FDA clearance of Giranel® Guiding Sheath Set further completes Kossel’s access device offering for the North American market. It enables a complete solution ranging from vascular access creation to balloon dilatation, lowering physicians’ costs associated with mixed vendor device selectio n and strengthening Kossel’s competitiveness as an integrated solution provider in North America.
Regulatory clearance goes hand-in-hand with commercial roll-out. Advancing its globalization strategy of “Local Base, Global Reach”, Kossel has established manufacturing sites in Europe and Southeast Asia. In 2021, Kossel acquired Ireland-based Micell, gaining access to thousands of global clinical datasets and proprietary specialty-coating technologies. To date, Kossel has secured more than 60 overseas registration certificates and generated revenue in over 20 countries. Since 2026, the company has continued to secure market authorizations in Japan, the United States, Singapore, Vietnam, Indonesia, Hong Kong SAR of China and other regions, expanding its global footprint.
From isolated product clearances toward multi-market, multi-product-line commercialization, Kossel’s global brand credibility has been continuously validated via rigorous regulatory evaluations. Moving forward, Kossel will continue to compete on the global stage by delivering product value, maintaining robust quality management systems and upholding full regulatory compliance. Its ultimate objective is to bring high-quality medical devices to healthcare facilities and patients worldwide — the core mission driving Kossel’s global expansion.