K193232

Substantially Equivalent

Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology

Applicant: Covidien, LLC
Product code: NEY
Advisory panel: General, Plastic Surgery
Date received: 2019-11-25
Decision date: 2020-02-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Boulder, CO, 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.