Decanting Device— 510(k) K182819

Substantially Equivalent

Gcmedica Enterprise Ltd.(Wuxi)

FDA 510(k) clearance K182819 for Decanting Device, Substantially Equivalent on 2019-12-02. Applicant: Gcmedica Enterprise Ltd.(Wuxi).

Clearance details

Applicant: Gcmedica Enterprise Ltd.(Wuxi)
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2018-10-04
Decision date: 2019-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuxi, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.