Company ยท US
Sonendo, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2021. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 2021 | K211995 | Sonendo Filling Material 5C Sonendo, Inc. | KIF |
| Feb 5, 2021 | K203302 | GentleWave X Sonendo, Inc. | ELC |
| Mar 16, 2019 | K190359 | Sonendo GentleWave System Sonendo, Inc. | ELC |
| Oct 22, 2018 | K181922 | Sonendo Material A Sonendo, Inc. | KIF |
| Jun 3, 2016 | K160905 | Sonendo GentleWave System Sonendo, Inc. | ELC |
| Jan 29, 2016 | K153157 | Sonendo Gentle Wave System Sonendo, Inc. | ELC |
| May 1, 2015 | K143448 | Sonendo GentleWave System Sonendo, Inc. | ELC |
| May 15, 2014 | K133752 | SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT Sonendo, Inc. | ELC |
| Jun 11, 2013 | K130025 | SONENDO ENDOTHERAPY SYSTEM Sonendo, Inc. | ELC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2022 | Sonendo Inc GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01 Open, Classified |
ELC | K190359 |
| Nov 14, 2022 | Sonendo Inc GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 Open, Classified |
ELC | K190359 |
| Oct 23, 2019 | Sonendo Inc GENTLEWAVE REF: FG-002-0001 Terminated |
ELC | K190359 |