PSW
7 FDA 510(k) clearances · Product code
179 daysmedian time to decision
263 days90th percentile
7clearances measured
FDA profile
- Official device name
- High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1570
- Medical specialty
- Radiology
- FDA 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).
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| Record | Firm | Date | Builder |
|---|
| TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator (K233049) | Cs Medical, LLC | 2023-11-21 | + Add |
| Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator (K230381) | Cs Medical, LLC | 2023-06-07 | + Add |
| CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant (K192228) | Cs Medical, LLC | 2020-04-01 | + Add |
| TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants (K182891) | Cs Medical, LLC | 2019-04-12 | + Add |
| 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 (K160921) | Cs Medical, LLC | 2016-11-03 | + Add |
| GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor (K150504) | Pci Medical, Inc. | 2015-11-16 | + Add |
| CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 (K051305) | Cs Medical, LLC | 2005-08-18 | + Add |
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Every clearance here is in the API, with alerts when new ones post.