New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter.— 510(k) K152031

Clearance details

Applicant

New Deantronics Taiwan , Ltd.

Product code

Code GEI

Device class

Class 2

Regulation

21 CFR 878.4400

Advisory panel

General, Plastic Surgery

Date received

2015-07-22

Decision date

2015-09-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tu Cheng City, TW

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• K201221 — Electrosurgical Generator2020-09-28
• K200455 — Trigger Switch and Cord2020-03-31

Death

133

Injury

7,585

Malfunction

35,808

Other

44

Total

43,570

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 →