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

Substantially Equivalent

New Deantronics Taiwan , Ltd.

FDA 510(k) clearance K152031 for 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., Substantially Equivalent on 2015-09-17. Applicant: New Deantronics Taiwan , Ltd..

Clearance details

Applicant: New Deantronics Taiwan , Ltd.
Product code: Code GEI
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

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.