Recall Z-0234-2023— Sonendo Inc

Name: FDA recall Z-0234-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-14

Class II · Ongoing

Class II FDA medical device recall by Sonendo Inc, initiated 2022-10-14. It names one FDA 510(k) clearance: K190359. Product: GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01. Reason: Procedure Instruments with erroneous unit carton labels..

Recalling firm: Sonendo Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-10-14
Firm location: Laguna Hills, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K190359 — Sonendo GentleWave SystemSonendo, Inc.·cleared 2019-03-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01

Reason for recall

Procedure Instruments with erroneous unit carton labels.

Data sourced from openFDA. This site is unofficial and independent of the FDA.