K233049 is an FDA 510(k) clearance for the TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator. This device is classified as a High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid (Class II - Special Controls, product code PSW).
Submitted by Cs Medical, LLC (Creedmoor, US). The FDA issued a Cleared decision on November 21, 2023, 57 days after receiving the submission on September 25, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 892.1570. 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) Number | K233049 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2023 |
| Decision Date | November 21, 2023 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PSW - High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |
| 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). |