CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice— 510(k) K201588

Substantially Equivalent

Varian Medical Systems, Inc.

FDA 510(k) clearance K201588 for CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice, Substantially Equivalent on 2020-08-11. Applicant: Varian Medical Systems, Inc..

Clearance details

Applicant: Varian Medical Systems, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2020-06-12
Decision date: 2020-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

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.