Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse— 510(k) K193336

Substantially Equivalent

Synedgen, Inc.

FDA 510(k) clearance K193336 for Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse, Substantially Equivalent on 2020-05-27. Applicant: Synedgen, Inc..

Clearance details

Applicant: Synedgen, Inc.
Product code: Code OLR
Advisory panel: Unknown
Date received: 2019-12-02
Decision date: 2020-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Claremont, CA, US

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Adverse events under product code OLR

product code OLR

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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