TEEClean Automated TEE Probe Cleaner Disinfector with TEEZyme Cleaner and TD-5 or TD-8 High Level Disinfectants
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182891 FDA 510(k)
- FDA Product Code
- PSW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1570 FDA 510(k)
- Regulation Number
- 892.1570 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TEEClean Automated TEE Probe Cleaner Disinfector is a High Level Disinfection Reprocessing Instrument for Ultrasonic Transducers, Liquid, designed specifically for automated cleaning and disinfection of transesophageal echocardiography (TEE) probes. It combines enzymatic cleaning with high-level disinfection to ensure thorough reprocessing of soiled probes, reducing manual labor and improving compliance with reprocessing protocols. The system adheres to radiology standards for probe hygiene, addressing the critical need for infection control in cardiac ultrasound procedures.
This device is intended for use in clinical settings, including cardiac catheterization labs and operating rooms, where TEE probes are routinely used. It operates as a reusable instrument, requiring pre-cleaning of probes at the bedside before automated reprocessing within the TEEClean unit. The system incorporates TD-5 or TD-8 high-level disinfectants alongside TEEZyme enzymatic cleaner, with a clearance under FDA_510K (K182891) as a Class II device under regulation 892.1570. Sterility is not applicable; the device is designed for reprocessing rather than single-use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TEEClean® Automated TEE Probe Cleaner Disinfector | Automated ..., TEEClean® Cleaner Disinfector - CS Medical, TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme (R ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182891 | Class II | Active |
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Manufacturer
- Manufacturer
- Cs Medical, Llc
Sources (1)
- FDA 510(k) K182891 24 fields · synced Oct 1, 2026