Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)— 510(k) K240975

Name: FDA 510(k) clearance K240975
Creator: U.S. Food and Drug Administration
Published: 2024-12-23

Substantially Equivalent

Beijing Taktvoll Technology Co., Ltd.

FDA 510(k) clearance K240975 for Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300), Substantially Equivalent on 2024-12-23. Applicant: Beijing Taktvoll Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Beijing Taktvoll Technology Co., Ltd.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2024-04-10
Decision date: 2024-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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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.