High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
The High Level Disinfection Reprocessing Instrument for Ultrasonic Transducers, Liquid is a device that uses liquid chemical agents to provide high-level disinfection of ultrasound transducers between patient uses, ensuring safe reuse in clinical settings. It is classified as FDA Class 2 under 21 CFR 892.1570 in the Radiology specialty, requiring 510(k) premarket notification; reprocessing validation data must be included in the submission. Product code PSW; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PSW
- Device Class
- FDA class 2
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233049 | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator | Nov 21, 2023 | Substantially Equivalent | Cs Medical, LLC |
| K230381 | Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator | Jun 07, 2023 | Substantially Equivalent | Cs Medical, LLC |
| K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant | Apr 01, 2020 | Substantially Equivalent | Cs Medical, LLC |
| K182891 | TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants | Apr 12, 2019 | Substantially Equivalent | Cs Medical, LLC |
| 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 | Nov 03, 2016 | Substantially Equivalent | Cs Medical, LLC |
| K150504 | GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor | Nov 16, 2015 | Substantially Equivalent | Pci Medical, Inc. |
| K051305 | CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 | Aug 18, 2005 | Substantially Equivalent | Cs Medical, LLC |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.