Sterile Aesthetic Cannula and Hypodermic Needle— 510(k) K223327
Substantially EquivalentShanghai Kindly Enterprise Development Group Co., Ltd.
FDA 510(k) clearance K223327 for Sterile Aesthetic Cannula and Hypodermic Needle, Substantially Equivalent on 2023-02-16. Applicant: Shanghai Kindly Enterprise Development Group Co., Ltd..
Clearance details
- Applicant
- Shanghai Kindly Enterprise Development Group Co., Ltd.
- Product code
- Code FMI
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, 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.