Sonendo, Inc.
Sonendo, Inc. holds FDA 510(k) medical device clearances, first cleared 2013, most recent 2021, with 3 FDA device recalls on record.
Top product codes for Sonendo, Inc.
FDA recalls by Sonendo, Inc.
- Z-0233-2023 — GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
- Z-0234-2023 — GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
- Z-2162-2020 — GENTLEWAVE REF: FG-002-0001
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Sonendo, Inc.
- K211995 — Sonendo Filling Material 5C
- K203302 — GentleWave X
- K190359 — Sonendo GentleWave System
- K181922 — Sonendo Material A
- K160905 — Sonendo GentleWave System
- K153157 — Sonendo Gentle Wave System
- K143448 — Sonendo GentleWave System
- K133752 — SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT
- K130025 — SONENDO ENDOTHERAPY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.