K240784

Substantially Equivalent

Temperature Sensor Probe (ABL-18TP20)

Applicant: Varian Medical Systems, Inc.
Product code: NEY
Advisory panel: General, Plastic Surgery
Date received: 2024-03-21
Decision date: 2024-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Adverse events under product code NEY

product code NEY

Death: 24
Injury: 388
Malfunction: 462
Other: 1
Total: 875

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.