FDA grants Thermedx 510(k) clearance for optional fluid warming in arthroscopic, hysteroscopic procedures

Thermedx, LLCJun 30 2014

Thermedx, LLC, an innovative designer and manufacturer of "smart" surgical irrigation products, received FDA 510(k) clearance for optional fluid warming in arthroscopic and hysteroscopic procedures. Building upon its prior FDA 510(k) clearance(s) for irrigation, distension, and deficit monitoring in gynecology, urology, and orthopedics, and optional fluid warming for urology, the fluid warming capabilities added to Thermedx's multi-functional Thermedx FluidSmart™ System provide hospitals and surgery centers with a single solution for surgical irrigation and optional warming within multiple disciplines.

"Our customers requested the expanded fluid warming capabilities added to our FluidSmart™ System for patient warming and other potential benefits. This clearance now allows for a unique comprehensive surgical irrigation system for gynecology hysteroscopic fluid management, urology irrigation in prostate, kidney stone, and bladder procedures, and in orthopedics for arthroscopy irrigation. Due to the clear visualization, pressure control, deficit monitoring, and optional fluid warming features, the FluidSmart™ System is becoming the preferred choice for an increasing number of hospitals and surgery centers," said Doug Carr, President & CEO of Thermedx. "We look forward to continued customer-driven innovation."

Thermedx is now the only company with FDA clearance to provide optional fluid warming, as part of its novel surgical irrigation system, specifically for gynecology and orthopedic endoscopic procedures.