SynePure Wound Cleanser— 510(k) K143444

Substantially Equivalent

Synedgen, Inc.

FDA 510(k) clearance K143444 for SynePure Wound Cleanser, Substantially Equivalent on 2015-08-21. Applicant: Synedgen, Inc..

Clearance details

Applicant: Synedgen, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2014-12-02
Decision date: 2015-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Claremont, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.