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

Clearance details

Applicant

Covidien, LLC

Product code

Code NEY

Device class

Class 2

Regulation

21 CFR 878.4400

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

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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 →