JUNIPER COOLING DEVICE XTRA— 510(k) K063715

Substantially Equivalent

Juniper Medical, Inc.

FDA 510(k) clearance K063715 for JUNIPER COOLING DEVICE XTRA, Substantially Equivalent on 2007-02-05. Applicant: Juniper Medical, Inc..

Clearance details

Applicant: Juniper Medical, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2006-12-14
Decision date: 2007-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.