Safety Pen Needle for Single Use, Insulin Pen Needles— 510(k) K212514
Substantially EquivalentBerpu Medical Technology Co., Ltd.
FDA 510(k) clearance K212514 for Safety Pen Needle for Single Use, Insulin Pen Needles, Substantially Equivalent on 2022-04-29. Applicant: Berpu Medical Technology Co., Ltd..
Clearance details
- Applicant
- Berpu Medical Technology Co., Ltd.
- Product code
- Code FMI
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wenzhou, CN
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.