truFreeze System— 510(k) K143625

Substantially Equivalent

CSA Medical, Inc.

FDA 510(k) clearance K143625 for truFreeze System, Substantially Equivalent on 2015-01-15. Applicant: CSA Medical, Inc..

Clearance details

Applicant: CSA Medical, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2014-12-22
Decision date: 2015-01-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

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.