KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX— 510(k) K022057
Substantially EquivalentKyung 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.. Device class: 2.
Clearance details
- Applicant
- Kyung GI Medical Ind. Co., Ltd.
- Product code
- Code FMI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- 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, through . 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.