Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology— 510(k) K193232

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K193232 for Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology, Substantially Equivalent on 2020-02-13. Applicant: Covidien, LLC.

Clearance details

Applicant: Covidien, LLC
Product code: 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

Download summary PDF View on FDA.gov ↗

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.