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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K190359
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GENTLEWAVE REF: FG-002-0001 2 05/28/2020 FEI # 3010817521
Sonendo Inc
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01 2 11/14/2022 FEI # 3010817521
Sonendo Inc
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 2 11/14/2022 FEI # 3010817521
Sonendo Inc
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