TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants

K182891 is the FDA 510(k) clearance record for TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants, a class II device, cleared for Cs Medical, LLC on 2019-04-12 under FDA product code PSW (High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid). FDA's definition for product code PSW reads: "To provide high level disinfection of ultrasound transducers If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807...". FDA records list 8 510(k) clearances for Cs Medical, LLC, from 2005-07-12 to 2023-11-21. As of 2026-09-10, FDA records show no recalls naming K182891.