CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1— 510(k) K012497

Substantially Equivalent

Galil Medical , Ltd.

FDA 510(k) clearance K012497 for CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1, Substantially Equivalent on 2001-10-30. Applicant: Galil Medical , Ltd..

Clearance details

Applicant: Galil Medical , Ltd.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2001-08-03
Decision date: 2001-10-30
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.