CRYOPRO MAXI AND CRYOPRO MINI— 510(k) K982280

Substantially Equivalent

Cortex Technology Aps

FDA 510(k) clearance K982280 for CRYOPRO MAXI AND CRYOPRO MINI, Substantially Equivalent on 1998-11-25. Applicant: Cortex Technology Aps.

Clearance details

Applicant: Cortex Technology Aps
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 1998-06-30
Decision date: 1998-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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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.