CS Medical announces FDA 510(k) clearance of TD-8®

CS Medical announces FDA 510(k) clearance of TD-8®

CS Medical is pleased to announce FDA 510(k) clearance of a new single-use, high-level disinfectant chemistry for the TD 100® Automated TEE Ultrasound Probe Disinfector. The FDA cleared high-level disinfectant TD-8 is OPA based and delivers a 5 minute high-level disinfection for TEE probes. The disinfectant will operate in the TD 100 identically to TD-5®, which was previously the only FDA cleared high-level disinfectant for the TD 100. CS Medical's President, Mark Leath stated, "I am pleased and excited to bring this additional high-level disinfectant solution to the healthcare market. We, at CS Medical, hope this product will continue to exceed both current and future customer expectations. I am extremely proud of our technical team for the development and delivery of this new high-level disinfectant chemistry."

For more than 10 years, CS Medical has provided the TD 100 Automated TEE Ultrasound Probe Disinfector to healthcare facilities throughout the United States. To date, the TD 100 has completed over 2.3 million successful disinfections with TD-5 and continues to provide validated and repeatable high-level disinfection for "dirty" TEE probes.

CS Medical is focused on all aspects of TEE ultrasound probe care with products like TEEZyme® enzymatic sponges, QwikDry® TEE drying cloths, electrical leakage testing, and HEPA filtered ultrasound probe storage. Our core product, the TD 100, is an example of our commitment to innovation and to the health and safety of medical patients and staff. CS Medical is pleased to be your partner in providing proven and effective solutions for TEE Complete Care.


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 TEEClean® 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 infections.

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.