ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK— 510(k) K111859

Substantially Equivalent

Galil Medical, Inc.

FDA 510(k) clearance K111859 for ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK, Substantially Equivalent on 2011-10-07. Applicant: Galil Medical, Inc..

Clearance details

Applicant: Galil Medical, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2011-06-30
Decision date: 2011-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Jackson, TX, 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.