K232200
- 510(k) number
- K232200
- Device name
- Disposable Injection Needles
- Applicant
- Ningbo Xinwell Medical Technology Co., Ltd. CN
- Product code
- FBK — Endoscopic Injection Needle, Gastroenterology-Urolog
- Decision date
- 2024-04-12
- Date received
- 2023-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232200.pdf
Official FDA record: K232200
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.