PSW — High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid Class II
Classification Details
- Product Code
- PSW
- Device Class
- Class II
- Regulation Number
- 892.1570
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Radiology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233049 | cs medical | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with | November 21, 2023 |
| K230381 | cs medical | Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High- | June 7, 2023 |
| K192228 | cs medical | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD- | April 1, 2020 |
| K182891 | cs medical | TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and | April 12, 2019 |
| K160921 | cs medical | CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Me | November 3, 2016 |
| K150504 | pci medical | GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endore | November 16, 2015 |
| K051305 | cs medical | CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD | August 18, 2005 |