K232442
- 510(k) number
- K232442
- Device name
- Disposable Endoscope Injection Needles
- Applicant
- Zhejiang Soudon Medical Technology Co., Ltd. CN
- Product code
- FBK — Endoscopic Injection Needle, Gastroenterology-Urolog
- Decision date
- 2023-11-09
- Date received
- 2023-08-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232442.pdf
Official FDA record: K232442
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.