CRYO-HIT— 510(k) K993965

Substantially Equivalent

Galil Medical , Ltd.

FDA 510(k) clearance K993965 for CRYO-HIT, Substantially Equivalent on 2000-02-18. Applicant: Galil Medical , Ltd..

Clearance details

Applicant: Galil Medical , Ltd.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 1999-11-23
Decision date: 2000-02-18
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.