VYBE RF Electrosurgical System— 510(k) K230968

Substantially Equivalent

ShenB Co., Ltd.

FDA 510(k) clearance K230968 for VYBE RF Electrosurgical System, Substantially Equivalent on 2023-07-06. Applicant: ShenB Co., Ltd..

Clearance details

Applicant: ShenB Co., Ltd.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2023-04-05
Decision date: 2023-07-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Seoul, KR

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.