ShiNeo Silicone Implant— 510(k) K222748

Substantially Equivalent

Shineo Technology Co., Ltd.

FDA 510(k) clearance K222748 for ShiNeo Silicone Implant, Substantially Equivalent on 2022-12-23. Applicant: Shineo Technology Co., Ltd..

Clearance details

Applicant: Shineo Technology Co., Ltd.
Product code: Code MIB
Advisory panel: Ear, Nose, Throat
Date received: 2022-09-12
Decision date: 2022-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code MIB

product code MIB

Injury: 146
Total: 146

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.