K241536 is an FDA 510(k) clearance for the trophon Wireless Ultrasound Probe Holder. This device is classified as a High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist (Class II - Special Controls, product code OUJ).
Submitted by Nanosonics Limited (Macquarie Park, AU). The FDA issued a Cleared decision on September 27, 2024, 120 days after receiving the submission on May 30, 2024.
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 | K241536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2024 |
| Decision Date | September 27, 2024 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | OUJ — High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist |
| 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). |