TD-5010 Lancing Device and TD-5084 Sterile Lancets— 510(k) K221419
Substantially EquivalentGostar Co., Ltd.
FDA 510(k) clearance K221419 for TD-5010 Lancing Device and TD-5084 Sterile Lancets, Substantially Equivalent on 2023-01-20. Applicant: Gostar Co., Ltd..
Clearance details
- Applicant
- Gostar Co., Ltd.
- Product code
- Code QRL
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Taipei City, TW
Adverse events under product code QRL
product code QRL- Other
- 1
- Total
- 1
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.