K182891 is an FDA 510(k) clearance for the TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants. 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 April 12, 2019, 179 days after receiving the submission on October 15, 2018.
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 | K182891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2018 |
| Decision Date | April 12, 2019 |
| Days to Decision | 179 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). |