CS Medical announces FDA 510(k) clearance of the TD 100®
The TD 100 is an automated disinfector designed to reduce the manual manipulation, complexity and length of time required to properly disinfect transesophageal (TEE) ultrasound probes. Utilizing a microprocessor controller, the TD 100 provides a simple user interface that guides the technician through the few steps of the high-level disinfection that require user input. Once initiated, the disinfection process continues automatically and alerts the technician at the end of the 17-minute cycle. The TD 100 eliminates the need for manual reprocessing, thereby saving time and providing printed verification of probe disinfection.
″The TD 100 is the first automated TEE disinfector on the market, and represents a significant step forward in disinfection technology,″ said Greg Dobbyn, CEO of CS Medical. ″Endoscope technicians have enjoyed this type of automated disinfection for a while now, and we've brought this same convenience and time savings to anyone tasked with handling and cleaning TEE probes.″
The TD 100 is the first and only automated TEE disinfector available in North America, and has received 510(k) clearance from the FDA.
Read more about the TD 100.
About CS Medical
Founded in 2003, CS Medical LLC is a leader in developing, manufacturing, and marketing medical devices that are
designed to provide cleaning and high-level disinfection of ultrasound probes. Our products are engineered and
developed with one single objective in mind: to minimize the potential of patient exposure to improperly
reprocessed ultrasound probes. Our core products, the
Automated TEE Probe Cleaner Disinfector and Ethos Automated Ultrasound Probe
Cleaner Disinfector, are examples of our ongoing commitment to innovation and to the health and safety
of medical patients and staff.
Beyond cleaning and high-level disinfection of endocavity and surface ultrasound probes, CS Medical believes in
managing the quality of care given to delicate ultrasound probes. Our product offering provides solutions for
healthcare facilities to minimize ultrasound probe damage and reduce the potential of contaminating high-level
disinfected probes prior to use. The products address the following areas: bedside cleaning, point of care
cleaning, electrical leakage testing, drying, transporting, and storing the ultrasound probe. Our objective is
to manage the care given to each ultrasound probe thus allowing for a reduction in healthcare associated
Located in Creedmoor, North Carolina, CS Medical's products provide quality device care and storage by minimizing
healthcare operational costs, improving device readiness, and increasing regulatory compliance.