Winter Park, FL, October 21, 2017 --(PR.com
)-- GENICON announced today that the U.S. Food and Drug Administration has granted 510(k) clearance for the Company’s X-Surge product group. This clearance extends GENICON’s portfolio of advanced laparoscopic Electro-Surgical Instrumentation (ESI) which now includes economically friendly single use shafts and actuating tips to work in concert with reusable handle assemblies along with the Company’s award winning complete single use instrumentation.
Designed with surgeon-directed enhancements, the X-Surge product group will now provide the global healthcare community with a comprehensive array of choices in their approach to meeting surgeons needs with laparoscopic ESI products.
GENICON is recognized as an emerging leader in the design, production, and distribution of patented surgical instrumentation focused exclusively on laparoscopic surgery. Founded in 1998 and based in Orlando, Florida, GENICON is a privately held firm in which several of their shareholders are surgeons who utilize their products. GENICON remains today as it originated: a company driven to meet the needs of modern-day healthcare through the harmonization of clinical needs and the economic demands of a global healthcare system.
Product concepts and ongoing development originate from a distinguished panel of surgeons within GENICON’s Clinical Product Review Board. The panel includes General, Gynecologic, Urologic and Pediatric Surgeons who provide insight to product design that will meet the needs of our global surgeon client base. GENICON’s Research & Development team, comprised of mechanical and electrical engineers richly experienced in medical device design and manufacturing, bring these concepts to reality.