Sonendo Inc
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 9
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0233-2023 | Class II | GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 | October 14, 2022 |
| Z-0234-2023 | Class II | GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01 | October 14, 2022 |
| Z-2162-2020 | Class II | GENTLEWAVE REF: FG-002-0001 | October 23, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K211995 | Sonendo Filling Material 5C | August 27, 2021 |
| K203302 | GentleWave X | February 5, 2021 |
| K190359 | Sonendo GentleWave System | March 16, 2019 |
| K181922 | Sonendo Material A | October 22, 2018 |
| K160905 | Sonendo GentleWave System | June 3, 2016 |
| K153157 | Sonendo Gentle Wave System | January 29, 2016 |
| K143448 | Sonendo GentleWave System | May 1, 2015 |
| K133752 | SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT | May 15, 2014 |
| K130025 | SONENDO ENDOTHERAPY SYSTEM | June 11, 2013 |