KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX— 510(k) K022057

Substantially Equivalent

Kyung GI Medical Ind. Co., Ltd.

FDA 510(k) clearance K022057 for KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX, Substantially Equivalent on 2002-11-22. Applicant: Kyung GI Medical Ind. Co., Ltd..

Clearance details

Applicant: Kyung GI Medical Ind. Co., Ltd.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2002-06-24
Decision date: 2002-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kimpo-Si, Kyunggi-Do, KR

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Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.