Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle— 510(k) K214063
Substantially EquivalentGuangzhou Shengwei Medical Devices Co., Ltd.
FDA 510(k) clearance K214063 for Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle, Substantially Equivalent on 2022-06-03. Applicant: Guangzhou Shengwei Medical Devices Co., Ltd..
Clearance details
- Applicant
- Guangzhou Shengwei Medical Devices Co., Ltd.
- Product code
- Code KNW
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Conghua City, CN
Adverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
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.