CRYOFLOW 700, CRYOFLOW 1000— 510(k) K052310

Substantially Equivalent

Uniphy Elektromedizin GmbH & Co. KG

FDA 510(k) clearance K052310 for CRYOFLOW 700, CRYOFLOW 1000, Substantially Equivalent on 2006-03-15. Applicant: Uniphy Elektromedizin GmbH & Co. KG.

Clearance details

Applicant: Uniphy Elektromedizin GmbH & Co. KG
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2005-08-24
Decision date: 2006-03-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bilzen, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.