K230925
- 510(k) number
- K230925
- Device name
- Disposable Injection Needle AF series
- Applicant
- Alton (Shanghai) Medical Instruments Co., Ltd. CN
- Product code
- FBK — Endoscopic Injection Needle, Gastroenterology-Urolog
- Decision date
- 2023-09-27
- Date received
- 2023-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K230925.pdf
Official FDA record: K230925
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.