Disposable Injection Needle AF series— 510(k) K230925
Substantially EquivalentAlton (Shanghai) Medical Instruments Co., Ltd.
FDA 510(k) clearance K230925 for Disposable Injection Needle AF series, Substantially Equivalent on 2023-09-27. Applicant: Alton (Shanghai) Medical Instruments Co., Ltd..
Clearance details
- Applicant
- Alton (Shanghai) Medical Instruments Co., Ltd.
- Product code
- Code FBK
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Adverse events under product code FBK
product code FBK- 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.