K252021
- 510(k) number
- K252021
- Device name
- Disposable Endoscopic Injection Needles
- Applicant
- Changzhou New Med Micro-Medtech Co., Ltd. CN
- Product code
- FBK — Endoscopic Injection Needle, Gastroenterology-Urolog
- Decision date
- 2025-12-02
- Date received
- 2025-06-30
- 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: K252021.pdf
Official FDA record: K252021
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.