Sungshim Insulin Pen Needle— 510(k) K152334
Substantially EquivalentSung Shim Medicare Co., Ltd.
FDA 510(k) clearance K152334 for Sungshim Insulin Pen Needle, Substantially Equivalent on 2016-03-17. Applicant: Sung Shim Medicare Co., Ltd..
Clearance details
- Applicant
- Sung Shim Medicare Co., Ltd.
- Product code
- Code FMI
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sejing-Si, KR
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.