Product code PSW

Device name: High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
Medical specialty: Radiology
Device class: 2
Regulation number: 892.1570
Review panel: HO
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: 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, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K233049	TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator	Cs Medical, LLC	2023-11-21
K230381	Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator	Cs Medical, LLC	2023-06-07
K192228	CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant	Cs Medical, LLC	2020-04-01
K182891	TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants	Cs Medical, LLC	2019-04-12
K160921	CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant	Cs Medical, LLC	2016-11-03
K150504	GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor	Pci Medical, Inc.	2015-11-16
K051305	CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5	Cs Medical, LLC	2005-08-18

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
B205CSECD1001	Ethos®	CS MEDICAL, LLC	2023-07-31
B205CSTD2001	TD 200®	CS MEDICAL, LLC	2020-04-15
B205CSTCD1000	TEEClean®	CS MEDICAL, LLC	2019-09-25

Related 510(k) Records#