K160921 is an FDA 510(k) clearance for the 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. 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 3, 2016, 213 days after receiving the submission on April 4, 2016.
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 | K160921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2016 |
| Decision Date | November 03, 2016 |
| Days to Decision | 213 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). |