CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5— 510(k) K980913

Substantially Equivalent

Galil Medical , Ltd.

FDA 510(k) clearance K980913 for CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5, Substantially Equivalent on 1998-07-01. Applicant: Galil Medical , Ltd..

Clearance details

Applicant: Galil Medical , Ltd.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1998-03-10
Decision date: 1998-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.