IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System— 510(k) K152133

Substantially Equivalent

Galil Medical , Ltd.

FDA 510(k) clearance K152133 for IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System, Substantially Equivalent on 2015-08-28. Applicant: Galil Medical , Ltd..

Clearance details

Applicant: Galil Medical , Ltd.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2015-07-31
Decision date: 2015-08-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Shaar Yokneam, IL

Download summary PDF View on FDA.gov ↗

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.