Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen— 510(k) K213146
Substantially EquivalentJiangsu Rongye Technology Co., Ltd.
FDA 510(k) clearance K213146 for Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen, Substantially Equivalent on 2023-10-27. Applicant: Jiangsu Rongye Technology Co., Ltd..
Clearance details
- Applicant
- Jiangsu Rongye Technology Co., Ltd.
- Product code
- Code JKA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jiangsu, CN
Adverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
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.